Neutrino Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared Nov 2024
Total Reports
1,320
Reports (30d)
15
Active Signals
1
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Remote Follow-Up Revealed T-Wave Over-Sensing
device technical, exhibited post, remote follow, support contacted, episodes post
13
reports
Remote Presentation with T-Wave Over-Sensing
net, remotely merlin, exhibited post, merlin net, adverse consequences
5
reports
MRI Mode Not Programmed, Device in Backup Mode
support contacted, resolve event, technical support, mri, mode
5
reports
Post-Paced T-Wave Over-Sensing with No Intervention
observed device, event patient, resolve event, sensing, patient implantable
5
reports
In-Clinic Follow-Up Revealed T-Wave Over-Sensing
support contacted, reprogramming, technical support, pptwos, device technical
5
reports
High Pacing Impedance During Implant Procedure
lead, impedance, event patient, resolve event, implant procedure
4
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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