Entrant Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared May 2024 · 4 device variants grouped
Total Reports
403
Reports (30d)
11
Active Signals
0
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Remote Oversensing Monitoring in Stable Condition
observed device, remote follow, support contacted, paced wave, oversensing pptwos
10
reports
Dislodged Left Ventricular Lead
left, lead, replaced, left ventricular, ventricular lead
4
reports
In-Clinic Oversensing Observation
observed device, support contacted, technical support, pptwos, device technical
2
reports
Remote Oversensing Reprogramming Success
observed device, remote follow, technical support, contacted recommended, device technical
1
reports
Device in Backup Mode
mode, icd, implantable cardioverter, cardioverter defibrillator, defibrillator icd
1
reports
T-Wave Oversensing Programming Discussion
implantable cardioverter, programming changes, cardioverter defibrillator, defibrillator icd, oversensing
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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