TRANSVENOUS LEAD Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)
Total Reports
376
Reports (30d)
2
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Dislodged / Lead Dislodged / Replaced Right
lead explanted, lead dislodged, dislodged, explanted replaced, replaced right
1
reports
Exhibited Oversensing / Oversensing Lead / Use Right
exhibited oversensing, lead explanted, use right, replaced right, oversensing lead
1
reports
Ipg / Pulse / Implantable Pulse
pulse, implantable pulse, pulse generator, generator ipg, ipg
1
reports
Lead Explanted and Replaced for Unknown Reason
adverse, infection, effects, reported lead, additional adverse
1
reports
Pacing Lead Explanted Due to Infection
pacing lead, infection, event patient, patient complications, result event
1
reports
RA Lead Exhibited Oversensing and Noise
noise, exhibited oversensing, exhibited noise, use right, oversensing
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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