MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Oct 2023
Total Reports
195
Reports (30d)
10
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Extravascular Lead P-Wave Oversensing
lead remains, extravascular lead, use, extravascular, oversensing
24
reports
Inappropriate Shocks from Noise
additional information, file, received file, file updated, updated lead
2
reports
Infection at Device Pocket Site
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Inspiration-related sensing failure of extravascular cardioverter defibrillator
Stanisław Tubek, et al. · Kardiologia Polska · 2025
Initial experience with the extravascular implantable cardioverter-defibrillator in pediatric patients
Mark P. Walsh, et al. · Heart Rhythm O2 · 2025
Extravascular implantable cardioverter-defibrillator implantation in a teenager with Brugada syndrome and recurrent inappropriate shocks of subcutaneous implantable cardioverter-defibrillator
Silvia Garibaldi, et al. · HeartRhythm Case Reports · 2025
Citations indexed from PubMed.
Keep exploring
CAPSUREFIX Novus
MEDTRONIC, INC. · 44,266 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 37,350 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 36,864 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 27,559 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 19,791 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,490 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
