RV LEAD Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD)
Total Reports
181
Reports (30d)
0
Active Signals
1
Open Recalls
82
What the reports describe · Claripulse analysis
Most commonly reported problems
Fracture / Ventricular Lead / Lead Explanted
lead explanted, fracture, voltage, explanted replaced, ventricular lead
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Oct 29, 2025 · Open, Classified
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Evidence
Related research
Subacute Apical RV Lead Microperforation in CRT Implantation
Ashesh Halder, et al. · JACC Case Reports · 2026
Apical Lead Position Increases the Risk of Right Ventricular Lead Perforation: A Retrospective Cohort Study
Yuji Manabe, et al. · Pacing and Clinical Electrophysiology · 2026
Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions
Tatyana Yevgenyevna Storozhenko, et al. · JACC. Clinical electrophysiology · 2025
RV lead placement – A forgotten cause of right heart failure
Muhammad Arslan Cheema, et al. · Annals of Medicine and Surgery · 2021
Citations indexed from PubMed.
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