BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2201795 · Received August 5, 2011

    Report

    Report Number
    1644487-2011-01795
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    April 27, 2010
    Report Date
    July 6, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S GENERATOR WAS REPLACED PROPHYLACTICALLY. FURTHER INFO REVEALS THAT THE PT HAD EXPERIENCED AN INCREASE IN SEIZURES ABOVE PRE-VNS BASELINE LEVELS BEGINNING AROUND (B)(6) 2010. THE INCREASE HAS POSSIBLY RESOLVED SINCE SURGERY PER PHYSICIAN. THE EXPLANTED GENERATOR WAS RETURNED TO THE MFR AND UNDERWENT ANALYSIS. UPON ANALYSIS, NO ANOMALIES WERE NOTED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 010904

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other