MEDTRONIC, INC. · CRT-Pacemaker (CRT-P) · First cleared Mar 2011
Total Reports
192
Reports (30d)
3
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Infection Leading to Device Explantation
infection, event patient, patient complications, complications, result event
3
reports
Oversensing Noise During Atrial Arrhythmia
noise, atrial, right, ventricular, lead
2
reports
CRT Device Explanted with No Allegations
post, reported cardiac, additional adverse, crt explanted, explanted replaced
1
reports
High Impedance Battery Analysis Request
reported request, impedance battery, battery device, potential high, device recorded
1
reports
Lead Set Screw Failure During Implant
generator, implantable pulse, lead, pulse generator, ipg
1
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).
Evidence
Citations indexed from PubMed.
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