Durata Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Implantable Cardioverter Defibrillator (ICD), Permanent Defibrillator Electrode (Lead) · First cleared May 1996 · 35 device variants grouped
Total Reports
20,299
Reports (30d)
160
Active Signals
0
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
RV Lead Oversensing and High Thresholds
condition, replaced patient, patient stable, clinic, capture
135
reports
Infection in Device Pocket
infection, pocket, condition patient, stable, patient presented
27
reports
Remote Monitoring Noise Oversensing
observed right, patient stable, continue monitored, remote, intervention performed
24
reports
RV Lead Exhibited Noise Oversensing
exhibited noise, intervention, revealed, patient presented, presented
16
reports
Rising Defibrillation Impedance in RV Lead
lead remains, pacing impedance, impedance, lead exhibited, use right
16
reports
Helix Damage During Implant Procedure
lead implanted, patient stable, used, implant procedure, helix
14
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
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
Defibrillation failure with short ICD charge time: Internal short circuit of a Durata lead.
Okada A, et al. · Journal of cardiology cases · 2019
Defibrillation failure with an electrical short circuit caused by internal insulation breach
Takuo Tsurugi, et al. · HeartRhythm Case Reports · 2021
Prospective long-term follow-up of silicone-polyurethane–insulated implantable cardioverter-defibrillator leads
John A. Cairns, et al. · Heart Rhythm O2 · 2021
Citations indexed from PubMed.
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