Entrant Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared May 2024
Total Reports
338
Reports (30d)
16
Active Signals
1
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Technical Support Recommended Reprogramming
observed device, reprogramming, support contacted, episodes post, adverse consequences
6
reports
High Pacing Impedance During Implant Procedure
lead, impedance, event patient, resolve event, implant procedure
4
reports
Remote Follow-Up Revealed T-Wave Over-Sensing
device technical, exhibited post, remote follow, support contacted, oversensing pptwos
3
reports
Post-Paced T-Wave Oversensing Observed
wave oversensing, paced wave, transmission, oversensing observed, post paced
2
reports
Post-Paced T-Wave Over-Sensing with No Further Info
implantable cardioverter, defibrillator exhibited, cardioverter, cardioverter defibrillator, post paced
2
reports
Remote Transmission Revealed T-Wave Over-Sensing
transmission revealed, remotely merlin, net review, merlin net, presented remotely
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Aug 16, 2023 · Open, Classified
Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.
Mar 10, 2022 · Open, Classified
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
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