Unidentified MEDTRONIC, INC. Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Pacemaker Pulse Generator
Total Reports
1,396
Reports (30d)
28
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Right Ventricular Lead Low Impedance Issues
right, impedance, lead exhibited, right ventricular, ventricular lead
21
reports
Post-Implant Infection with Antibacterial Envelope
absorbable envelope, absorbable, antibacterial absorbable, antibacterial, envelope
19
reports
Periprocedural Complications in Pediatric Patients
groups, burden, patients, periprocedural complications, group
7
reports
CIED Infections Leading to Patient Deaths
cardiovascular, patients, death, diagnosis, cied
7
reports
Premature Battery Depletion of Pulse Generator
battery, implantable pulse, pulse generator, generator ipg, ipg
6
reports
Inappropriate Device Therapy and Patient Deaths
devices, atrial, patients, inappropriate, death
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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