ABBOTT (ST. JUDE MEDICAL) · CRT-Pacemaker (CRT-P) · First cleared May 2004
Total Reports
1,164
Reports (30d)
20
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Far-Field Oversensing Causing Mode Switch
intervention, stable, presented, oversensing, mode
15
reports
Lead Set Screw Failure During Implant
generator, implantable pulse, lead, pulse generator, ipg
7
reports
Infection Leading to Device Explantation
infection, event patient, patient complications, complications, result event
6
reports
Template Summary: Device Field Analysis
received indicating, analyzed, noise, observed, field
3
reports
Premature Battery Depletion and Replacement
use, crt exhibited, explanted replaced, premature battery, battery depletion
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
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. 1 active signal detected right now.
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