MEDTRONIC, INC. · CRT-Pacemaker (CRT-P) · First cleared Mar 2011
Total Reports
1,352
Reports (30d)
25
Active Signals
2
Open Recalls
1
What the reports describe · Claripulse analysis
Infection Leading to Device Explantation
infection, event patient, patient complications, complications, result event
21
reports
Oversensing Noise During Atrial Arrhythmia
noise, atrial, right, ventricular, lead
8
reports
Premature Battery Depletion and Replacement
use, crt exhibited, explanted replaced, premature battery, battery depletion
7
reports
Lead Set Screw Failure During Implant
generator, implantable pulse, lead, pulse generator, ipg
6
reports
Template Summary: Device Field Analysis
received indicating, analyzed, noise, observed, field
2
reports
CRT Device Explanted with No Allegations
post, reported cardiac, additional adverse, crt explanted, explanted replaced
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Apr 6, 2021 · Open, Classified
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
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