RV LEAD Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD)
Total Reports
308
Reports (30d)
1
Active Signals
0
Open Recalls
82
What the reports describe · Claripulse analysis
Most commonly reported problems
Implantable Lead Revision Due to Infection
lead explanted, infection, revision, effects, additional adverse
5
reports
High Shock Impedance Measurements Observed
impedance measurements, measurements, shock impedance, ohms, range
1
reports
Potential EMI Affecting ICD Function
noise, implantable cardioverter, episode, cardioverter defibrillator, defibrillator icd
1
reports
RV Lead Revision for Infection
lead explanted, infection, effects, revision, additional adverse
1
reports
Suspected Lead Fracture in RV Lead
suspected, lead explanted, fracture, voltage, low
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions
Tatyana Storozhenko, et al. · JACC. Clinical electrophysiology · 2025
Left ventricular free wall perforation by a right ventricular pacemaker lead: a case report
Natsuko Satomi, et al. · European Heart Journal - Case Reports · 2021
Twiddler's syndrome resulting in right phrenic nerve stimulation: a case report.
Asjad SJ, et al. · European heart journal. Case reports · 2026
Outcomes of Entrapped Right Ventricular Pacing or Defibrillator Leads Following Transcatheter Tricuspid Valve Replacement
Graham Peigh, et al. · JACC: Cardiovascular Interventions · 2025
Pacemaker lead-associated tricuspid regurgitation in patients with or without pre-existing right ventricular dilatation
Martin Riesenhuber, et al. · Clinical Research in Cardiology · 2021
Citations indexed from PubMed.
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