Pamira S 65 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Jan 2023
Total Reports
180
Reports (30d)
12
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explant Due to Dislodgement
additional information, received file, file updated, dislodgement, updated lead
7
reports
Lead Explant Due to Oversensing and Shocks
lead capped, inappropriate, channel, oversensing, shocks
5
reports
System Explant Due to Infection
additional information, infection additional, received file, file updated, explanted infection
3
reports
Explanted System Due to Infection
additional information, infection additional, file updated, monitored, explanted infection
2
reports
Lead Dislodgement with Helix Malfunction
replaced patient, patient stable, high capture, consequences, helix
1
reports
Lead Capped for High Shock Impedance
patient events, received file, events reported, file updated, updated lead
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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