Shayla Anne Walmsley · Prevention of Future Deaths report

The investigation into the death of Shayla Anne Walmsley was opened on 21 May 2013 and concluded at the end of the inquest on 4 July 2014. The cause of death was unascertained and the conclusion of the inquest was narrative ████████

Miss Walmsley was found deceased at her home residence on 9 May 2013. She had a background medical history of diabetes mellitus. Owing to difficulties with controlling her diabetes she was started on a Medtronic insulin pump in 2009. She found this to be beneficial and I heard evidence at the inquest that she did not report any concerns about its functioning.

In December 2012 the MHRA asked all insulin pump manufacturers to provide details of issues that had been raised regarding these devices. Medtronic were unable to provide this detail until May 2013. I heard evidence that this data was held at Medtronic’s facilities in the USA and that it could not be made available to non-US regulators in any shorter timescale. For the sake of clarity, there was no evidence that this delay contributed to Miss Walmsley’s death.

In April 2013 Medtronic issued a Field Safety Notice (FSN) into three issues that had been reported as affecting the function of insulin pumps. I was provided with evidence that Miss Walmsley received this FSN by recorded delivery. Two further FSNs were issued later in 2013, although by that time Miss Walmsley had died.

I heard evidence from a representative of the Governance Department of the NHS Trust, which provided Miss Walmsley with the insulin pump, regarding the systems in place for receiving and cascading FSNs. It was clear that FSNs (in general) were often not addressed to the most appropriate department or individual within the Trust and, as such, sometimes did not reach those who could take the necessary action. On occasion patients had raised concerns to the Trust, following their receipt of an FSN, before the appropriate individual within the trust had themselves been made aware of the issuing of an FSN.

I heard from Medtronic and the MHRA that, if insufficient feedback has been received from the recipients of an FSN, this could trigger the MHRA to issue a Medical Device Alert (MDA) through the Central Alerting System (CAS). This is an online reporting tool which links directly to NHS Trusts (amongst others). MDAs were issued through CAS for each of the FSNs which related to Medtronic insulin pumps in 2013.

A post mortem examination was undertaken as part of the investigation into Miss Walmsley’s death, which did not elucidate a cause of death. The presence of a ‘Medical Device’, which I concluded was the insulin pump, was noted during the examination but was not further analysed. I heard evidence from the pathologist who undertook the post mortem that he did not know the nature of the device and had received no instruction to analyse the device from the Coroner who requested the post mortem.

Medtronic provided evidence that insulin pumps have, on occasion, been returned to them for analysis from police officers and pathologists who are investigating deaths of pump users. Unfortunately this did not occur as part of the investigation into the death of Miss Walmsley. The cause of her death remained unascertained at the conclusion of the inquest.

(1) Interval to availability of Medtronic data - I am concerned that the investigatory role of non-US regulators could be hampered by the timescale within which Medtronic can provide data on request. Given the potential consequences of a delay in production of this safety data, I believe that future deaths could result and that this warrants consideration by Medtronic.

(2) Inconsistency in issuing FSNs - I am concerned that the apparently ad hoc nature by which FSNs are issued applies inappropriate individuals within NHS Trusts being aware of safety concerns and that this could result in future deaths. It is clear the CAS distributes MDAs to NHS Trust governance departments in a reliable manner. I believe that consideration should be made as to whether CAS could be used also to distribute FSNs.

I heard evidence from the governance department representative that this would not lead to ‘alert fatigue’ (where receipt of numerous alerts results in less attention being paid to them). This is because governance departments should be receiving these FSNs in any case and taking steps to distribute as appropriate. I heard concerns from the MHRA that this view may not be shared by all governance departments but, in my judgement, there should be consideration of the use of CAS for FSN distribution.

(3) Non-analysis of medical devices at post mortem - I am concerned that future investigations into the deaths of medical device users could be impaired by the lack of analysis of medical devices at post mortem. It is clear that these devices are increasingly being used by patients and, if death is unexplained in such a patient, appropriate analysis should be considered. As such, I believe that it is necessary to emphasise, to those involved in death investigation, the potential importance of device analysis.