Protego SD 65/18 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
220
Reports (30d)
3
Active Signals
0
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
2
reports
Noise on Multiple Channels
additional information, received file, file updated, channel, remains implanted
2
reports
System Explanted Due to Infection
additional information, infection, infection additional, patient stable, file updated
2
reports
Lead Capped for Noise and Fracture
additional information, file, lead capped, file updated, updated lead
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.
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