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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.