BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2052547 · Received April 8, 2011

    Report

    Report Number
    1644487-2011-00719
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 11, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT WAS REFERRED FOR BATTERY REPLACEMENT AS THE GENERATOR WAS "OUT OF POSITION" AND PAINFUL. THE PATIENT UNDERWENT THE REPLACEMENT SURGERY AND THE PRODUCT WAS SENT BACK TO THE MANUFACTURER FOR ANALYSIS, WHICH HAS NOT BEEN COMPLETED TO DATE. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 7083

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention