Plexa ProMRI Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998 · 9 device variants grouped
Total Reports
5,188
Reports (30d)
50
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explant Due to Oversensing and Shocks
lead capped, inappropriate, channel, oversensing, shocks
28
reports
System Explant Due to Infection
additional information, infection additional, received file, file updated, explanted infection
15
reports
Lead Explant Due to Noise and Impedance
patient events, events reported, file updated, updated lead, reported additional
15
reports
Lead Capped for High Shock Impedance
patient events, received file, events reported, file updated, updated lead
14
reports
Noise on Multiple Channels with Lead Remains
additional information, received file, file updated, channel, remains implanted
12
reports
Lead Explant Due to Inappropriate Shocks
additional information, received file, file updated, updated lead, shocks
10
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Citations indexed from PubMed.
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