MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead) · First cleared Aug 1996 · 7 device variants grouped
Total Reports
43,528
Reports (30d)
607
Active Signals
6
Open Recalls
0
What the reports describe · Claripulse analysis
Undersensing During Atrial Events
pacing times, tachycardia atrial, resulting termination, implant right, times lead
124
reports
Abrupt Impedance Changes in RV Lead
event patient, patient complications, reported right, patient experienced, result event
106
reports
Termination of Detected Atrial Events
resulting termination, episodes resulting, fibrillation stored, atrial pacing, event progress
67
reports
High Thresholds in Ventricular Lead
implant right, post implant, exhibited high, thresholds lead, replaced
51
reports
Rising Impedance in Ventricular Lead
impedance, high impedance, impedance lead, rising, ventricular lead
48
reports
Infection Leading to CRT Device Explant
crt, infection, cardiac resynchronization, resynchronization therapy, crt explanted
43
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Intra-atrial block requiring dual-site atrial pacing through a femoral approach in a univentricular heart.
Marinelli A, et al. · 2020
Late ventricular pacemaker lead perforation after electrical cardioversion-A case report.
Vandenberk B, et al. · 2022
Surgical management of left bundle branch pacing lead causing septal and left ventricular perforation.
Hernandez M, et al. · 2023
Ventricular tachycardia due to delayed septal perforation by a left bundle branch area pacing lead.
Hsieh JC, et al. · 2023
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. 6 active signals detected right now.
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