Pamira S DX 65/15 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
227
Reports (30d)
16
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explanted Due to Dislodgement
file, received file, dislodgement, file updated, updated lead
13
reports
Pocket Infection Leading to Explant
infection, received file, infection additional, pocket, file updated
9
reports
Lead Explanted for Shock Impedance Issue
patient events, events reported, file updated, updated lead, reported additional
2
reports
Lead Explanted for Under-Sensing
revision, dislodgement, leads, reported lead, explanted replaced
2
reports
Right Ventricular Lead Undersensing
episode, undersensing, remain, use right, integrity
1
reports
High Shock Impedance Measurement
received file, file updated, shock impedance, ohms, remains implanted
1
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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