BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1822469 · Received August 26, 2010

    Report

    Report Number
    1644487-2010-01956
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THEY HAD A PT WHO WAS ADMITTED TO THE HOSPITAL FOR INCREASED DEPRESSION. IT WAS REPORTED THAT THEIR DEPRESSION WAS LIKELY OVER THEIR PRE VNS RATE, BUT RELATIONSHIP TO THEIR VNS IS UNK. NO DIAGNOSTICS WERE PERFORMED. THE PT HAD HER DEVICE TEMPORARILY DEACTIVATED IN ORDER TO RECEIVED ECT TREATMENT, WHICH SHE HAS PREVIOUSLY RESPONDED TO. IT IS UNK IF THE PT HAD ANY MEDICATION CHANGE OR LIFE EVENT PRIOR TO THE ONSET OF THEIR INCREASED DEPRESSION. GOOD FAITH ATTEMPTS THUS FAR HAVE BEEN UNSUCCESSFUL ATTAINTING ANY FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 015790

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R