ABBOTT ICD Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Implantable Cardioverter Defibrillator (ICD)
Total Reports
202
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
1
reports
High Shock Impedance Measurements in RV Lead
impedance measurements, measurements, impedance, shock impedance, range
1
reports
Inappropriate ATP and Shock Delivery
svt, fibrillation, tachycardia, ventricular tachycardia, detected
1
reports
Inappropriate Shock from Oversensing Noise
subcutaneous, subcutaneous implantable, effects, inappropriate, vector
1
reports
Oversensing Detected During Remote Follow-Up
reprogramming, stable, oversensing, contacted, technical
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
When ICDs Do Not Deliver: The Unseen Burden of Untreated Arrhythmias.
Monkhouse C, et al. · Arrhythmia & electrophysiology review · 2026
Novel findings of an old algorithm: PVC response "Atrial Pace'' initiates atrial arrhythmias in Abbott ICD and CRT-D devices.
Sane M, et al. · Pacing and clinical electrophysiology : PACE · 2022
Citations indexed from PubMed.
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