MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Jan 2019 · 2 device variants grouped
Total Reports
469
Reports (30d)
2
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
RV Lead Exhibited T-Wave Oversensing
oversensing twos, lead remains, wave oversensing, lead exhibited, use right
2
reports
RV Lead Triggered Lead Integrity Alert
integrity alert, lead integrity, alert lia, lia, integrity
2
reports
RV Lead Exhibited Oversensing
lead remains, lead exhibited, counter sic, use right, oversensing
1
reports
ICD Explanted Due to Infection with Vegetation
infection, event patient, patient complications, icd explanted, result event
1
reports
RV Lead Oversensing Causing Pacing Inhibition
patient complications, alert lia, result event, lia, integrity
1
reports
RV Lead Reprogrammed and Remains in Use
lead explanted, reprogrammed, reprogramming, coil, fracture
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
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