Pamira S DX 65/15 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Jan 2023
Total Reports
264
Reports (30d)
10
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
14
reports
System Explant Due to Infection
additional information, infection additional, received file, file updated, explanted infection
5
reports
Noise on Multiple Channels with Lead Remains
additional information, received file, file updated, channel, remains implanted
4
reports
Explanted System Due to Infection
additional information, infection additional, file updated, monitored, explanted infection
3
reports
Helix Malfunction During Lead Implant
lead implanted, used, new lead, implant procedure, helix
1
reports
High Pace Impedance Measurements Noted
impedance measurements, measurements, remains service, effects, ohms
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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