MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead) · First cleared Sep 1986 · 2 device variants grouped
Total Reports
3,716
Reports (30d)
51
Active Signals
3
Open Recalls
0
What the reports describe · Claripulse analysis
Pacing Lead Capped and Replaced
pacing lead, lead capped, replaced, used replaced, attempted used
9
reports
Rising Impedance in Ventricular Lead
impedance, high impedance, impedance lead, rising, ventricular lead
8
reports
High Thresholds in Ventricular Lead
thresholds lead, replaced, thresholds, exhibited high, replaced right
6
reports
Low Impedance and High Thresholds in Leads
impedance, high impedance, leads, exhibited high, ventricular lead
6
reports
Undersensing During Atrial Events
progress, pacing times, tachycardia atrial, events, resulting termination
6
reports
Far Field Oversensing in Atrial Lead
exhibited far, ffrw, wave ffrw, field wave, ffrw oversensing
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
A Rare Case of Complete Fragmentation of Pacemaker Lead after a High-Velocity Theme Park Ride.
Khattak F, et al. · 2018
Late perforation of a passively fixated pacemaker lead through the right ventricle. A report and review of literature.
Demo H, et al. · 2017
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. 3 active signals detected right now.
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