ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared May 2004
Total Reports
402
Reports (30d)
5
Active Signals
1
Open Recalls
2
What the reports describe · Claripulse analysis
Programming Changes Made to Resolve Issue
additional information, reprogramming, resolve event, resolve, programming changes
2
reports
Far R Wave Oversensing Observed
icd, implantable cardioverter, cardioverter, cardioverter defibrillator, wave
1
reports
ICD Set Screw Failure During Implant
implant procedure, implantable cardioverter, icd, cardioverter defibrillator, defibrillator icd
1
reports
Infection with Device Pocket Erosion
explanted, icd, infection, pocket, ventricular lead
1
reports
Lead Connection Failure During Implant
replaced, event patient, resolve event, explanted replaced, implant procedure
1
reports
Remote Follow-Up Oversensing Observed
observed device, remote follow, support contacted, technical support, device technical
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
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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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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