Linox Smart S DX 65/17 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Jul 2013
Total Reports
480
Reports (30d)
3
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Capped for Noise and Fracture
additional information, file, lead capped, file updated, updated lead
3
reports
Lead Explanted for Oversensing and Shock
received file, lead capped, inappropriate, channel, oversensing
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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