Protego S 65 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Jul 2014
Total Reports
1,225
Reports (30d)
13
Active Signals
0
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
17
reports
Lead Capped for High Shock Impedance
patient events, received file, events reported, file updated, updated lead
4
reports
Lead Explant Due to Inappropriate Shocks
additional information, received file, file updated, updated lead, shocks
2
reports
High Pace Impedance Measurements Noted
impedance measurements, measurements, remains service, effects, ohms
1
reports
Lead Explant Due to Noise and Impedance
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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