Pamira S DX 65/15 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
254
Reports (30d)
11
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explanted Due to Dislodgement
additional information, file, dislodgement, file updated, updated lead
12
reports
Noise on Multiple Channels
additional information, received file, file updated, channel, remains implanted
6
reports
Template Summary: Infection Update
additional information, received file, infection additional, file updated
4
reports
System Explanted Due to Infection
additional information, infection, infection additional, patient stable, file updated
3
reports
Right Lead Exhibited Undersensing
episode, lead remains, undersensing, use, use right
1
reports
Lead Explanted Due to Noise
patient events, events reported, file updated, updated lead, reported additional
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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