Geoffrey Duke

Salaried GPs

Darvin
Medical Practice

Our Ref: GY/ACG

3 July 2019
PRIVATE AND CONFIDENTIAL

SIGNIFICANT EVENT REPORT AND ACTION RE;

Geoftre aiie ue mu ee _ 20/12/2017
Late of - :

Geoffrey Duke, a patient registered at this practice died in the Royal Stoke Hospital on 20 December 2017.
This followed a prolonged period of illness, during which it was unclear quite what was wrong with him.
Eventually, and unfortunately too late to prevent his demise, this was found to be as a result of infection
arising from his pacemaker leads. This is seemingly an extremely unusual occurrence and was not thus
recognised in several hospital admissions that had taken place prior to this final admission to hospital in
Stoke.

As the GP who was responsible for seeing Mr Duke during most of his visits to the surgery ahead of his death,
| have been tasked to write this report, advocated by the coroner at his inquest, given that it was felt there
needs to be a structured plan to consider this possibility, should there be any further future instance thereof in
any other individual.

The clinicians at Darwin Medical Practice have met and discussed in depth this case on Thursday 20 June
2019, as part of our regular Clinical Governance Meeting.

The practice shared the information from HM Coroner and looked back, in detail, through Mr Duke’s medical
record. It was agreed that this was an extremely unusual occurrence. It was agreed that the clinicians
concerned in Primary Care had made all appropriate steps to try and elucidate. However, during his
attendances at the surgery, there could be seen no way that this could have been picked up earlier within
Primary Care. Mr Duke had attended on a number of occasions with relatively non-specific symptoms of
malaise, with the only finding being of raised inflammatory markers; rightly this had been noted and
documented and was being addressed and followed up. In fact, at the last time he was seen at the surgery,
he had improved in himself, as indeed had these clinical markers. it was noted that he was concurrently
having hospital admissions and attendances.

ness and the unexpected nature of the eventual outcome, the learning from this in Primary Care
isnow perceived as a possibility, where it may not have been considered before; the cause for
Mr Duke’é majAise. It was felt the remit for the final diagnosis lay probably more within Secondary Care, but
e/lessgh to be learned from this was that situations, even as unusual as this, are possible and should be

DR GEORGE YOUNG

All correspondence to, Branch surgeries: and

‘St. Chad’s Health Centre, Burntwood Health Centre, ‘Chasetown Medical Centre,
Dimbles Lane, Lichfield, Hudson Drive, Bumtwood, 29-31 High Street, Burntwood,

Staffordshire, WS13 7HT. Staffordshire, WS7 OEW. Staffordshire, WS7 3XE.

Telephone: 01543 412980 Telephone: 01543 682654 or Telephone: 01543 671705

darwinmedicalpractice.co.uk darwinmedical.practice@nhs.net

NHS)

University Hospitals Birmingham

NHS Foundation Trust
Medical director Trust Headquarters
Medical Director {0121 371 4329 Queen Elizabeth Hospital Birmi eal
. ms
oon Ref: : 0121 431 4316 Mindelsohn Way, Edgbaston
. a Birmingham
Your Ref fl 815 26W
uly 2019 Tel: 0121 627 2000
Margaret Jones

HM Assistant Coroner for Stoke on Trent and North Staffordshire
Coroner's Chambers

§47 Hartshill Road

Stoke-on-Trent

ST4 6HF

Sent by way of email: coroners@stoke.gov.uk

Dear Mrs Jones,

Inquest touching the death of Mr Geoffrey Duke
Response to Regulation 28 Report to prevent future deaths

| write in response to the Regulation 28 Report made by you following the Inquest
into the death of Mr Duke, which concluded on 14 May 2019.

University Hospitals Birmingham NHS Foundation Trust (the Trust) has carefully
considered the concems raised within your report to prevent future deaths. Before |
address the specific concern you raise, | would like to provide some detail as to the
number of pacemakers placed within our Trust and the outcome of an audit that has
been undertaken which includes the incidence of pacemaker related infection.

1. Review of pacemaker complications for both new implants and upgrades

The incidence of pacemaker related endocarditis is low in comparison to other
systemic infections. Most recent data suggests an incidence of approximately 4.5
cases per 1,000 pacemaker implants, giving an incident of 0.45%. The infection rate
following a pacemaker change has an incidence of 1% within the first year.

There were 1474 new implants/upgrades/ device changes undertaken by our Trust
during the last financial year. Infection is a recognised complication of these
procedures. Most recent audits of new implants undertaken in the Trust show an
infection rate of 0% at 3 months on our QEHB site in 2018 and 0.65% at our
Heartlands, Good Hope and Solihull sites in 2015. There is ongoing audit however
based on the evidence we have, we have not noticed any increase in reporting of
infection post procedure. International published data (see reference below)

Chair: Rt Hon Jacqui Smith Chief Executive: Dr David Rosser

suggests infection rates of 0.5-0.8% for new implants and 1-4% for device revisions
(generator changes, upgrades or lead replacements).

2. Treatment provided to Mr Duke

Mr Duke had a dual chamber pacemaker fitted in 2007 for complete heart block.
Most devices require a battery change at around 5 to 7 years depending on use. Mr
Duke underwent a box change on 15 June 2016 which also included a change of the
atrial lead as the impedance had dropped significantly. There were no complications
noted following the change in June 2016.

Mr Duke attended our ambulatory care clinic on 6 February 2017 where he was
assessed by a Consultant Physician. His presentation was in keeping with a
diagnosis of community acquired pneumonia for which he received antibiotics.
Blood cultures were taken which were negative at this time, which would have been
against the diagnosis of a pacemaker related endocarditis.

Mr Duke was asked to return on 8 February when he was noted to be improving. We
did not see Mr Duke again.

3. Cardiology referral for unwell patients who have undergone pacemaker
procedure

We have an embedded referral process to our cardiology team on each of our sites
for patients who present with suspected acute cardiac problems. This consists of a
daily Consultant Cardiologist ward round at the Queen Elizabeth Hospital and a
Consultant of the week available for consultation at Heartlands, Good Hope and
Solihull Hospitals.

Our data shows that there are on average 15 — 20 referrals per day to the cardiology
team on each of our sites (60 - 80 referrals per day across our Trust) of patients with
suspected acute cardiac problems. We are satisfied that our cardiology referral
process works effectively across all our sites which can be evidence by the number
of referrals to the cardiology team per day.

We do know that device related endocarditis is a rare and often covert infection.
There is no national algorithm available to assist in the diagnosis of pacemaker
related endocarditis and no evidence base to design a specific algorithm. It is
recognised nationally that awareness of device related endocarditis amongst
physicians is an issue and that in the absence of clear signs of pacemaker pocket
infection, a diagnosis of pacemaker related endocarditis is often delayed as
referenced in the ‘Guidelines for the diagnosis, prevention and management of
implantable cardiac electronic device infection. Report of a joint Working Party
project on behalf of the British Society for Antimicrobial Chemotherapy (BSAC, host
organization), British Heart Rhythm Society (BHRS), British Cardiovascular Society
(BCS), British Heart Valve Society (BHVS) and British Society for Echocardiography
(BSE) J Antimicrob Chemother 2014)’.

4. Action Plan

Having reviewed our referral process to our cardiology teams, we are satisfied that
we have in place an effective referral process however as a result of your report we
have undertaken a review of our endocarditis guidelines to ensure they are robust
and we are assured that our guidelines are comprehensive and include specific
reference to device related infection and endocarditis and therefore do not require
any amendment.

Our review of the literature suggests that one of the key issues in the delay in
diagnosing device related endocarditis is a lack of awareness amongst both patients
and acute physicians.

To raise awareness of pacemaker related endocarditis amongst our acute
physicians, we are undertaking a programme of education which will be provided via
our grand round to alert our staff to the possibility of pacemaker endocarditis. This
will be undertaken in the next academic term (September - December 2019).

We will also be sending out a ‘Lesson of the Month’ which is an email which goes out
to all staff with the aim to raise awareness of the signs and symptoms of pacemaker
related endocarditis. This will be circulated within the next 4 weeks.

We have also reviewed the patient information leaflets which are provided to all
patients following pacemaker insertion. The leaflets already contain information on
symptoms which might represent possible infection and provide details of who the
patient should contact if they are concerned. Whilst we are satisfied that the
information leaflets contain sufficient information for patients, we will be updating
them to include additional instructions where patients have symptoms of possible
infection, in particular the leaflet will indicate that if the patient has a fever and
temperature above 38 degrees Celsius, then they should a) seek medical attention
and b) inform their treating clinician that they have a pacemaker and that device
related endocarditis should be considered. Our aim is to update the leaflets by the
beginning of November 2019.

| would like to assure you that the concems raised within the Regulation 28 Report
have been taken extremely seriously which | hope is demonstrated by the steps we
have taken in reviewing our processes and guidelines and which we will be taken to
raise awareness of device related infection.

Yours sincerely,

Professor Simon Ball
Medical Director

NHS

University Hospitals of

‘Derby and Burton
NHS Foundation Trust
Our Ref: JS/WM/249/GD p . Royal Derby Hospital
Telephone: 01332 785 971 {Uttoxeter Road
Email Address: nn. ; Derby
DE22 3NE
Private and confidential
Mrs M Jones
HM Assistant Coroner for Stoke —on —Trent & North Staffordshire
547 Hartshill Road
Hartshill
Stoké on Trent .
_ST4 6HF . . 26 July 2019
Dear Madam,

Re: Regulation 28 report to prevent future Seaties following the inquest touching upon
Lio death of Mr Geoffrey Duke

lam writing | in response to your Regulation 28 Report sated dso” May 2019 following the inquest

touching upon the death of Mr Geoffrey Duke.

| understand that during the inquest you identified concerns arising from the absence of a
referral process for patients who have undergone pacemaker’ surgery who become unwell. It
was identified that there was no referral to a cardiologist which led to a failure to identify that Mr
Duke had become unwell due to an infection associated with a pacemaker insertion. | would like
to begin by offering an assurance that the Trust has taken’ steps to address the issues. that you
have identified, to ensure that there are mechanisms in place to prevent this occurring in the
~ future.

The Trust has implemented the following actions to ensure gee) identification, diagnosis
and referral to a cardiology specialist for patients who “have a suspected infection following a
pacemaker insertion: co:

| can confirm that the enclosed (appendix 1) Cardiac Implantable Electronic Device Lead
- Infection Microbiology Hospital Guideline has been developed by the Antimicrobial Pharmacist,
Cardiology Consultants and Microbiology Consultants. The document provides guidance on the
detection and treatment of Subacute Bacterial Endocarditis (SBE) related to cardiac rhythm
devices. This is now subject to the Trust's governance process to formally sign the guidance off.

Once formally signed off, this guidance will be linked to the Trust's existing guidance for Pyrexia
of Unknown Origin (PUQ) as guidance for patients presenting with ‘pyrexia (temperature) of
unknown origin with a cardiac rhythm device in place.

The final draft and: final signoff in conjunction with a communication plan will be complete by
30 September 2019. Once sign off has been completed, the guidelines will be accessible to all

staff through the Trust's intranet (called ‘Flo’). In addition, the Divisional Medical Director and

Divisional Nursing: Director will ensure that this information is disseminated to all the Clinical

Smoking is not permitted anywhere In the bulidings and
grounds of Derby Teaching Hospitals. For advice and support.
« Chair: John Rivers CBE DL -about giving up smoking please call freephone 6800 022'4332. Chief Executive: Gavin Boyle

NHS

University Hospitals of
Derby and Burton

Directors within each of the Trust's divisions, and tabled at their medical meeli#gerunee ign Tey

Staff.

The development of this guideline supports the previous learning board shared with all Doctors
in the Department of Medicine and the discussion at the Acute Medicine Mortality meeting in
May 2019, in raising awareness with the relevant teams. For ease. |_ have also enclosed a
further copy of the learning board (appendix 2), Statement of (appendix 3) and SI
report (appendix 4) to confirm the steps that the Trust is taking.

This will be further supported at the Trust-wide Quality Summit on 26 September 2019 where | |

with discuss this case and the learning that has been undertaken. It is hoped that
aspects of the summit will be captured on videos and podcasts that will be available on Flo. ;
Finally, EEE will also highlight-this learning within his‘ monthly ‘Patient Safety Brief’
newsletter (August 2019) that is sent fo all staff to further highlight the guidelines and the
learning following this case.

Conclusions

The Trust has shared the leaming from the inquest with the department of medicine to raise
awareness. This has been supported by a review of the guidance available to clinicians, within
the Organisation, relating to the identification and diagnosis of infection associated with a
cardiac rhythm device. Following this review guidance has been developed and will be linked to
the guidance relating to pyrexia of unknown origin. ‘

| trust that you will be: satisfied that these changes have addressed the issues that you
identified. The Trust would very much welcome your feedback on the changes that have been

made to strengthen the care and management of patients with infection associated with cardiac
rhythm devices.

Please do not hesitate to let me know if you require any further information from the Trust.

Yours sincerely

* Gavin Boyle
CHIEF EXECUTI

Smoking is not permitted anywhere in the buildings and
® grounds of Derby Teaching Hospitals. For advice and support

‘Chair: John Rivers CBE DL about giving up smoking please call freephone 0800 022 4332. Chief Executive: Gavin Boyle
,