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.

Device may exhibit:intermittent or permanent loss of pacing output without warning
intermittent or permanent loss of telemetry
reversion to ventricular inhibited pacing (VVI), and/or a reset warning message upon interrogation.Guidant has informed MHRA that all INSIGNIA and NEXUS implantable pacemakers may be subject to either one or two separate failure modes each having a different root cause.Affected devices will exhibit one or more of the following:intermittent or permanent loss of pacing output without warning
intermittent or permanent loss of telemetry
reversion to ventricular inhibited pacing (VVI), and/or a reset warning message upon interrogation.Although there have been no reports of death as a result of these failure modes, serious health complications may result from the abnormal device behaviours associated with these failure modes.Details of the two failure modes are described below:
Device Family
Model Numbers
NEXUS Entra SSI
1325, 1326
NEXUS Entra DDD
1425, 1426
NEXUS Entra SR
1395, 1398
NEXUS Entra DR
1466, 1494, 1495
NEXUS Ultra SR
1390
NEXUS Ultra DR
1490, 1491
NEXUS Plus SR
1394
NEXUS Plus DR
1467, 1468
NEXUS AVT SSI
1328
NEXUS AVT VDD
1428
NEXUS AVT DDD
1432
NEXUS AVT SR
1392
NEXUS AVT DR
1492NB. Not all models are available in the UKA list of UK serial numbers for devices distributed on or before 12 March 2004, affected by the first failure mode can be found in Appendix 1.
Device Family
Model Numbers
INSIGNIA Entra SSI
0484, 0485
INSIGNIA Entra DDD
0985, 0986
INSIGNIA Entra SR
1195, 1198
INSIGNIA Entra DR
1294, 1295, 1296
INSIGNIA Ultra SR
1190
INSIGNIA Ultra DR
1290, 1291
INSIGNIA Plus SR
1194
INSIGNIA Plus DR
1297, 1298
INSIGNIA AVT SSI
482
INSIGNIA AVT VDD
882
INSIGNIA AVT DDD
982
INSIGNIA AVT SR
1192
INSIGNIA AVT DR
1292
Guidant has identified the potential for loss of pacing output and/or telemetry in a subset of INSIGNIA and NEXUS devices distributed prior to 12 March 2004.Guidant has confirmed that the root cause of this malfunction is the obstruction of a crystal timing component by loose material used in the component’s manufacturer. When this timing component is disrupted all device operations such as pacing, telemetry and magnet response may be prevented and the device can cease to function.To date, all device malfunctions associated with this failure mode have occurred within the first 22 months of implantation. Guidant believes that the likelihood of this malfunction occurring decreases with implant time, with a mean time to failure of seven months.Device failure is rare. As of November 2005, Guidant has received three reports of syncope and six reports of bradycardia requiring emergency hospitalisation. Engineering analysis by Guidant of an explanted device revealed that it had failed briefly but then resumed functioning with no detectable indication to the physician during routine follow-up.Guidant has received 37 confirmed reports of device malfunction associated with this failure mode: 7 devices exhibited a no output condition during the implant procedure; 21 devices exhibited a no output condition post implant procedure and 9 devices reverted to VVI pacing at 65 bpm.Out of 49,500 devices distributed prior to 12 March 2004, Guidant estimates that approximately 41,000 devices remain implanted, with approximately 2,200 implanted in the UK.Guidant predicts that up to 14 additional devices may malfunction worldwide over the remaining lifetime of the implanted products. Guidant has ensured corrective measures to address this issue have been implemented.MHRA has received two UK reports of syncope associated with these devices. Guidant issued information related to this problem to UK clinicians on 29 September 2005 (see Appendix 2).
Guidant has identified that all INSIGNIA and NEXUS devices may exhibit a no output condition during verification testing prior to implant or during implantation. No malfunctions have been observed after successful verification of the device at implant.As of November 2005, Guidant has received 17 confirmed reports of device malfunction at pre-implant testing or during implantation out of approximately 341,000 devices distributed worldwide. In one (non-UK) report a pacemaker dependent patient experienced syncope and was resuscitated following cardiac arrest. This was associated with loss of pacing output during an elective pacemaker replacement procedure.There have been no reports of device malfunction at pre-implant testing or during implantation in the UK to date. The number of potentially affected devices in the UK is approximately 11,000.Guidant has yet to determine a specific root cause for this failure mode and continues to investigate this failure.Guidant will issue further advice when more information is available.Guidant also issued information related to this problem on 29 September 2005 (see Appendix 2).MHRA will continue to monitor both these situations.