Protego SD 65/18 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
210
Reports (30d)
1
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explanted for Shock Impedance Issue
patient events, events reported, file updated, updated lead, reported additional
2
reports
Remote Monitoring Noise Oversensing
remotely, transmission, revealed, patient presented, presented
2
reports
Right Ventricular Lead Impedance Issue
noted right, sensing, intervention, wave, patient consequences
2
reports
Inappropriate Shocks from Oversensing
lead capped, inappropriate, channel, oversensing, shocks
1
reports
Pocket Infection Leading to Explant
infection, received file, infection additional, pocket, file updated
1
reports
Lead Capped 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.
Detection
Active safety signals
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