Protego SD 65/18 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Jul 2014
Total Reports
223
Reports (30d)
3
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
2
reports
Explanted System Due to Infection
additional information, infection additional, file updated, monitored, explanted infection
1
reports
Lead Explant Due to Inappropriate Shocks
additional information, received file, file updated, updated lead, shocks
1
reports
Noise on Multiple Channels with Lead Remains
additional information, received file, file updated, channel, remains implanted
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Citations indexed from PubMed.
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