DISCLAIMER: Apart from official CHRS advisories or template letters, the CHRS does not necessarily endorse the views expressed in any of these external documents.
A subset of devices from the ACCOLADE family has an increased potential to initiate Safety Mode during higher-power operations due to latent high battery impedance. During normal high-power operations (e.g. telemetry) high battery impedance may cause a device to exhibit transient voltage decreases, which
may trigger a system reset. If three (3) system resets occur within a 48-hour period, the device is designed to enter Safety Mode to maintain backup pacing with pre-defined, non-programmable settings [unipolar RV (or BiV) sensing/pacing at VVI @ 72.5 ppm with high output (5.0V at 1.0 msec)]. Although therapy is still provided, the reset to unipolar pacing and sensing when in Safety Mode may result in adverse effects via myopotential oversensing-associated pacing inhibition, loss of AV/VV synchrony, and phrenic nerve stimulation. Moreover, replacement is required as the device is non-programmable.
Abbott has identified a programmer software anomaly that may be encountered in a very specific circumstance during intraoperative finalization of the AVEIR™ DR Leadless Pacemaker (LP) System. A specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. In this circumstance the RV leadless pacemaker is configured as an RA device. As the RV device is responsible for the control of pacing, the loss of “command” from the RV device leads to a loss of pacing. This can occur during a new AVEIR DR system implant or during an upgrade from an AVEIR VR to an AVEIR DR system.
Boston Scientific has issued an advisory relating to the occurrence of atrio-esophageal (AE) fistula with the use of the POLARxä and POLARxä FIT cryoablation catheters. In post-market surveillance, Boston Scientific has identified a higher-than-expected events of AE fistula.
Boston Scientific has not identified any incident of catheter or any equipment malfunction contributing to these cases. However, review of these cases suggested a possible role of the frequency and intensity of cryoablation contributing to adverse outcomes. This has led to updates to the instructions for use, to avoid potential factors that may increase the risk of AE fistula.
Medtronic has released a software update for the SmartSync tablet programmer.
This update aligns the nominal settings and programming screens with the programming recommendations from the May 2023 communication (listed below). As a result of this update, devices interrogated with an updated SmartSync tablet programmer (device application software 2.1.0 or higher) are no longer considered to be in scope of this advisory.
Updates to the CareLink Encore™ and CareLink™ 2090 programmers will be released at a future date.
Please read the attached document for further details.
Click here for product performance reports for alternative devices.
REVEAL LINQ Insertable Cardiac monitor (LNQ11)
LINQ II Insertable Cardiac monitor (LNQ22)
ASSURITY™ AND ENDURITY™ PACEMAKERS MODELS PM1160, PM1172, PM1240, PM1272, PM2160, PM2172, PM2240, PM2260, PM2272
Potential for Premature Battery Depletion in a Subset of Medtronic ICD and CRT-D Devices: Claria MRI™/Amplia MRI™/Compia MRI™/Viva™/Brava CRT-Ds™/Visia AF™/Visia AF MRI™/Evera™/Evera MRI™ ICDs
Note: Firmware update resolving the issue August 2017.
Note: Firmware update resolving the issue confirmed March 2019.
Risk of RF interference causing inappropriate in-clinic programming.
This advisory describes a battery malfunction with the St. NanoStim™ Leadless Cardiac Pacemaker (LCP) system.
This advisory relates to an increased risk of premature, and possibly sudden, battery depletion with the St. Jude Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra ICDs manufactured before May 23, 2015.
Devices manufactured after May 23, 2015 are not affected by this advisory.
Models Affected:
CD1411-36Q / CD2411-36C / CD2377-36QC
CD1411-36C / CD1377-36QC / CD2377-36C
CD2411-36Q / CD1377-36C
Delay or loss of high voltage therapies may occur subsequent to the rare circumstance of 3 “simultaneous” events, which can be corrected with an anticipated software release.