Neutrino Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared Nov 2024
Total Reports
1,333
Reports (30d)
4
Active Signals
0
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Device in Backup Mode After MRI
support contacted, resolve event, technical support, mri, mode
3
reports
Remote Oversensing Monitoring in Stable Condition
observed device, remote follow, support contacted, technical support, device technical
2
reports
Device Explanted Due to ERI Status
additional information, resolve event, device reprogrammed, explanted replaced, explanted
1
reports
In-Clinic Oversensing Observation
observed device, support contacted, technical support, pptwos, device technical
1
reports
Inappropriate Therapy Delivery Due to Signal Misinterpretation
resolve event, patient stable, technical support, inappropriate, delivered
1
reports
Remote Oversensing Reprogramming Success
observed device, remote follow, technical support, contacted recommended, device technical
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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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