MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Oct 2023
Total Reports
1,318
Reports (30d)
66
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Abandoned Implant Procedure Due to Oversensing
extravascular lead, use, wave, extravascular, implant procedure
53
reports
Inappropriate Shock from Oversensing
additional information, received file, patient complications, extravascular lead, file updated
40
reports
Multiple Episodes of Oversensing Noise
episodes, wave oversensing, oversensing noise, extravascular lead, use
38
reports
Explanted ICD Due to Infection
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
12
reports
Low Impedance Alert on Extravascular Lead
alert, extravascular lead, use, low, lead impedance
10
reports
Reprogramming Performed
crt, reprogramming, clinic, use, reported additional
7
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. 1 active signal detected right now.
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