FORTIFY ASSURA VR ICD, US Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Implantable Cardioverter Defibrillator (ICD)
Total Reports
3,392
Reports (30d)
0
Active Signals
0
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Reprogrammed After MRI Backup Mode
reprogrammed, high voltage, stable, contacted, technical
5
reports
ICD Backup Mode Post-MRI Scan
measurements, implantable cardioverter, high range, cardioverter defibrillator, defibrillator icd
3
reports
Device Interrogation Failure Reported
clinic, stable, device remains, remains implanted, technical
2
reports
Premature Battery Depletion Observed
implantable cardioverter, depletion, battery, cardioverter defibrillator, defibrillator icd
2
reports
RV Lead Capped and Replaced
tachycardia pacing, tachycardia, delivered, anti tachycardia, atp
2
reports
Noise Oversensing Detected Remotely
noise, programming, lead exhibited, defibrillator icd, stable
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
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
Mar 10, 2022 · Open, Classified
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
Mar 10, 2022 · Open, Classified
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
Evidence
Related research
Sasaki T, et al. · International heart journal · 2019
Barcellini A, et al. · La Radiologia medica · 2022
Citations indexed from PubMed.
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