INSIGNIA and NEXUS implantable pacemakers 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

Recall due to component failure.The information provided in this alert is an update to the information provided in MDA/2005/067 issued on 08 December 2005 which advised of two failure modes, which were described as: ‘First failure mode’ and ‘Second failure mode’.This Alert provides updated information concerning the second failure mode. There is no change to previous information provided about the first failure mode.Guidant has initiated a world-wide recall of certain INSIGNIA and NEXUS implantable pacemakers and has now identified why a subset of these devices exhibits no output conditions during verification testing prior to implant or during the implantation procedure (the second failure mode).Guidant has identified that these devices can malfunction if they incorporate a defective crystal timing component manufactured by one of two suppliers.Guidant has determined that a problem with the manufacturing process of this component can, in rare instances, result in a microscopic particle of quartz crystal entering the internal cavity of the crystal timing component. This particle can electrostatically attach to the inner surface of the crystal casing and subsequently detach through normal handling or during transit. The loose particle can then adhere to the crystal tuning mechanism causing crystal malfunction, and consequential malfunction of the master oscillator circuit that controls all pacemaker timing functions. Malfunction of the master oscillator will result in intermittent/permanent loss of pacing or telemetry.Although all models of INSIGNIA and NEXUS implantable pacemakers are affected, this recall is restricted to those devices that have been assembled using defective crystal timing components (see list of affected serial numbers distributed in the UK on our website).To date, Guidant has received 17 confirmed reports of device malfunction out of 257,000 devices distributed worldwide. These all occurred at pre-implant testing or during the implantation procedure.There have been no reports of device malfunction in the UK at pre-implant testing or during the implantation procedure. The number of potentially affected devices in the UK is approximately 8,000.Since all failures have occurred before or during the implantation procedure neither Guidant nor MHRA advise additional follow-up for successfully implanted devices at this time.Guidant also issued updated information related to this problem to UK clinicians on 16 December 2005 (see Appendix 1).MHRA will continue to monitor the situation and will consider issuing further advice.