CapSure Sense Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Sep 1986 · 2 device variants grouped
Total Reports
3,414
Reports (30d)
30
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Not Used Due to Deployment Issues
pacing lead, attempted, used replaced, attempted used, used
11
reports
Thresholds / Use Right / High Thresholds
thresholds lead, thresholds, exhibited high, use right, high thresholds
4
reports
RA Lead Dislodged Post Implant
lead explanted, implant right, lead dislodged, dislodged, post implant
4
reports
Ipg / Pulse / Implantable Pulse
pulse, implantable pulse, pulse generator, generator ipg, ipg
3
reports
Undersensing on Stored Electrograms
stored, tachycardia atrial, atrial tachycardia, electrograms egm, egm
3
reports
RA Lead Exhibited High Thresholds
thresholds lead, exhibited high, use right, oversensing, high thresholds
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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