Gallant ICD Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Implantable Cardioverter Defibrillator (ICD) · First cleared Apr 2023 · 5 device variants grouped
Total Reports
4,225
Reports (30d)
83
Active Signals
0
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Inappropriate Shock Delivered by ICD
implantable cardioverter, icd, shock, cardioverter defibrillator, defibrillator icd
22
reports
Remote Monitoring Oversensing Episodes
merlin net, net review, presented remotely, net, remotely merlin
17
reports
ICD in Backup Mode Post-MRI
mode, implantable cardioverter, icd, cardioverter defibrillator, mri
15
reports
Dislodged Left Ventricular Lead
left, lead, replaced, left ventricular, ventricular lead
11
reports
Pocket Infection and Erosion
right, lead, infection, pocket, patient presented
10
reports
Post-Paced T-Wave Oversensing Observed
oversensing, contacted recommended, implantable cardioverter, observed device, support contacted
10
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.
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