Protego S 65 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
1,212
Reports (30d)
10
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explanted for Oversensing and Shock
received file, lead capped, inappropriate, channel, oversensing
9
reports
Lead Capped for Noise and Fracture
additional information, file, lead capped, file updated, updated lead
5
reports
Increasing Shock Impedance Observed
received file, file updated, shock impedance, ohms, remains implanted
2
reports
High Out-of-Range Defibrillation Impedance
triggered, impedance, coil, use, use right
1
reports
Lead Explanted Due to Noise
patient events, events reported, file updated, updated lead, reported additional
1
reports
RV Lead Capped Due to Noise
file, patient events, events reported, 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.
Detection
Active safety signals
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