MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1996
Total Reports
164
Reports (30d)
1
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
High Thresholds in Atrial Lead
thresholds lead, replaced patient, event right, exhibited high, result event
1
reports
Infection Leading to CRT Device Explant
cardiac resynchronization, crt, infection, resynchronization therapy, crt explanted
1
reports
Loss of Capture on RV Lead
implantable pulse, patient complications, pulse generator, generator ipg, ipg
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Implantable Cardioverter-Defibrillator (ICD) Lead-Induced Septal and Left Ventricular Perforation in Hypertrophic Cardiomyopathy: A Case Report.
Alexiou P, et al. · 2026
Contralateral pneumothorax, pneumomediastinum, and pneumopericardium after dual-chamber pacemaker implantation.
Santos MP, et al. · 2025
Case report: inadvertent misplacement of pacemaker leads in the left ventricle and left circumflex artery.
Fröhlich M, et al. · 2025
Feasibility of cardiac magnetic resonance imaging in temporary permanent pacemaker implants in pediatric myocarditis and complete atrioventricular block.
Kakarla S, et al. · 2024
Citations indexed from PubMed.
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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.
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