ABBOTT (ST. JUDE MEDICAL) · CRT-Defibrillator (CRT-D) · First cleared Apr 2018
Total Reports
274
Reports (30d)
1
Active Signals
1
Open Recalls
2
What the reports describe · Claripulse analysis
Clinic Follow-Up Oversensing Observed
icd, changes, presented clinic, programming changes, defibrillator icd
1
reports
Infection with Device Pocket Erosion
explanted, icd, infection, pocket, ventricular lead
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
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
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
Evidence
Cardiac Resynchronization Therapy Delivered Via a Multipolar Left Ventricular Lead is Associated with Reduced Mortality and Elimination of Phrenic Nerve Stimulation: Long-Term Follow-Up from a Multicenter Registry.
Behar JM, et al. · 2015
Citations indexed from PubMed.
Keep exploring
CAPSUREFIX Novus
MEDTRONIC, INC. · 43,528 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 36,855 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 36,335 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 27,017 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 19,619 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,450 reports
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
Get Early AccessUnderstanding this data
