MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Apr 2017 · 2 device variants grouped
Total Reports
4,690
Reports (30d)
55
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Explanted ICD Due to Infection
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
20
reports
Lead Integrity Alert Triggered
triggered, sensing, alert, use, integrity
18
reports
Low Out-of-Range Pacing Impedance Alert
triggered, alert, defibrillation, use right, impedances
13
reports
T-Wave Oversensing Resulting in Episodes
episodes, wave oversensing, use right, resulting, result event
12
reports
High Defibrillation Impedance Observed
defibrillation impedance, use, exhibited high, patient consequences, consequences
8
reports
Undersensing Observed on Right Ventricular Lead
episodes, sensing, therapy, use, use right
8
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 2 active signals detected right now.
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