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PULSE GEN MODEL 106 Adverse Event — Injury (MDR 1644487-2020-00643)

PULSE GEN MODEL 106 Adverse Event — Injury (MDR 1644487-2020-00643) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PULSE GEN MODEL 106; Generic name: GENERATOR; Manufacturer: CYBERONICS - HOUSTON.

DevicePULSE GEN MODEL 106
Generic nameGENERATOR
ManufacturerCYBERONICS - HOUSTON
Report number1644487-2020-00643
Event typeInjury
Product problemN
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE, HEALTH
NarrativeDEVICE EVALUATED BY MANUFACTURER? DEVICE EVALUATION IS NOT NECESSARY AS REPORTED EVENT(S) ARE NOT RELATED TO THE FUNCTIONALITY OR DELIVERY OF THERAPY OF THE DEVICE.
SourceopenFDA MAUDE (device adverse events)

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