Plexa ProMRI S 60 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
236
Reports (30d)
4
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Oversensing with Abnormal Impedance
additional information, updated, received file, events reported, file updated
5
reports
Rising Shock Impedance with Noise-Induced Pacing Inhibition
ventricular, right, impedance, right ventricular, ventricular lead
2
reports
System Explant for Infection
additional information, updated, infection additional, file updated, explanted infection
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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