Durata Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Implantable Cardioverter Defibrillator (ICD), Permanent Defibrillator Electrode (Lead) · First cleared May 1996 · 36 device variants grouped
Total Reports
20,458
Reports (30d)
132
Active Signals
3
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Oversensing Episodes Resolved by Lead Replacement
resolve event, observed right, patient stable, capped replaced, oversensing
40
reports
Lead Dislodgement with Helix Malfunction
replaced patient, patient stable, high capture, consequences, helix
35
reports
ICD System Explant Due to Infection
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
31
reports
Remote Oversensing Monitoring with No Action
observed right, patient stable, continue monitored, remote, intervention performed
26
reports
High Pacing Impedance Capped and Replaced
replaced patient, pacing impedance, patient stable, high pacing, capped replaced
20
reports
Noise Oversensing with Programming Changes
changes, revealed, patient presented, oversensing, intervention performed
14
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
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
Sudden and Fatal Malfunction of a Durata Defibrillator Lead due to External Insulation Failure.
Shah AD, et al. · Pacing and clinical electrophysiology : PACE · 2015
Performance of the Durata implantable cardioverter defibrillator lead: results of an independent multicenter study.
Rordorf R, et al. · Journal of cardiovascular medicine (Hagerstown, Md.) · 2019
Citations indexed from PubMed.
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