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
19,969
Reports (30d)
159
Active Signals
15
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Remote Monitoring Noise Oversensing
observed right, patient stable, continue monitored, remotely, remote
44
reports
Oversensing Observed with Stable Patient
condition, observed right, patient stable, oversensing, intervention performed
43
reports
Lead Over-Sensing Noise During Implant
attempted, lead implanted, stable, implant procedure, helix
41
reports
RV Lead Dislodgement Noted in Follow-Up
replaced patient, patient stable, dislodged, patient presented, stable
38
reports
Infection at Device Pocket Site
implantable cardioverter, infection, pocket, stable condition, patient presented
19
reports
High Pacing Impedance and Non-Capture
replaced patient, lead capped, pacing impedance, high pacing, capped
18
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.
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