Quadra Assura MP Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared Apr 2018 · 8 device variants grouped
Total Reports
10,531
Reports (30d)
41
Active Signals
3
Open Recalls
2
What the reports describe · Claripulse analysis
Most commonly reported problems
Remote Transmission Revealed T-Wave Over-Sensing
transmission revealed, remotely merlin, net review, merlin net, presented remotely
12
reports
Remote Presentation with T-Wave Over-Sensing
net, remotely merlin, exhibited post, merlin net, adverse consequences
9
reports
Remote Follow-Up Revealed T-Wave Over-Sensing
device technical, exhibited post, observed device, remote follow, support contacted
9
reports
MRI Mode Not Programmed, Device in Backup Mode
support contacted, resolve event, technical support, mri, mode
8
reports
Infection and Skin Erosion at Device Pocket
right, lead, infection, pocket, ventricular lead
7
reports
In-Clinic Follow-Up Revealed T-Wave Over-Sensing
device technical, icd, support contacted, reprogramming, clinic follow
6
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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