BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1801198 · Received August 11, 2010

    Report

    Report Number
    1644487-2010-01847
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 12, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE VNS DEPRESSION PT WAS HOSPITALIZED FOR A SUICIDE ATTEMPT. THE PT STATED THAT SHE WAS IN A COMA AND WAS INTUBATED FOR 2 DAYS. THE RELATIONSHIP OF THE EVENT TO VNS IS UNK. IT IS UNK IF THE EVENT WAS ABOVE, BELOW OR BACK TO PRE-VNS BASELINE AND IF ANY PROGRAMMING OR MEDICATION CHANGES CONTRIBUTED TO THE EVENT. MOREOVER, IT IS UNK IF ANY INTERVENTIONS HAVE BEEN PLANNED OR TAKEN. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 MUZ CYBERONICS, INC. 103 200828

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| L