Shayla Walmsley

1. 1. delay in provision of safety data by Medtronic

   “Interval to availability of Medtronic data I am concerned that the investigatory role of nonUS 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. 2. ad hoc issuance of Field Safety Notices

   “Inconsistency in issuing FSNs I am concerned that the apparently ad hoc nature by which FSNs are issued delays appropriate individuals within NHS Trusts being aware of safety concerns and that this could result in future deaths. It is clear the 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.”

3. 3. lack of post mortem device analysis

   “Nonanalysis 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 2 involved in death investigation, the potential importance of device”

No published response was found on judiciary.uk.