LEAD Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Permanent Pacemaker Electrode (Lead)
Total Reports
472
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
RA Lead Exhibited Noisy Signals
noise, crt, adverse, remains service, effects
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
Evidence
Related research
Left arm twitching caused by failure of pacemaker lead insulation.
Kido S, et al. · CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2026
Indication-stratified early outcomes after transvenous lead extraction in hemodialysis patients: Analysis of a prospective 1256-patient registry.
Shah KB, et al. · Heart rhythm O2 · 2026
Transvenous Lead Extraction in a Real-World Cohort: Clinical Characteristics, Outcomes, and Performance of the SAFeTY Score.
Racman M, et al. · Journal of clinical medicine · 2026
Comparative Analysis of Extraction Complications in Transvenous Versus Leadless Pacemakers.
Sahyouni A, et al. · Cureus · 2026
Transapical epicardial temporary pacemaker lead implantation in patients with transapical TAVI.
Liang C, et al. · Open heart · 2026
Citations indexed from PubMed.
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 46,343 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 39,061 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 38,591 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 29,411 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,458 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,669 reports
Want automated safety signal detection?
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