MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)
Total Reports
4,527
Reports (30d)
27
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Lead Capped Due to Performance Issue
lead capped, effects, form, service, additional adverse
9
reports
Noisy Signals and Low Impedance in Atrial Lead
adverse, effects, reported right, range, service
8
reports
High Pacing Thresholds in Ventricular Lead
adverse, effects, reported right, additional adverse, ventricular lead
4
reports
High Out of Range Impedance in Ventricular Lead
adverse, impedance, effects, range, service
4
reports
Rising Impedance in Leads
impedance, fracture, thresholds, reported lead, high thresholds
3
reports
Lead Explanted Due to Performance Issue
adverse, effects, form, additional adverse, explanted
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Early sudden distal conductor fracture of a stylet-driven lead implanted for left bundle branch area pacing
Raffael Thaler, et al. · HeartRhythm Case Reports · 2022
Effective date of requirement for premarket approval for cardiovascular permanent pacemaker electrode. Final rule.
Food and Drug Administration, et al. · 2012
A Primer to the Structure, Content and Linkage of the FDA's Manufacturer and User Facility Device Experience (MAUDE) Files.
Ensign LG, et al. · 2017
Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death.
Lalani C, et al. · 2021
Polycythemia and the heart. A review.
Venegoni P, et al. · 1994
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
