BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2092162 · Received April 27, 2011

    Report

    Report Number
    1644487-2011-00912
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT SURGERY, THE NEW GENERATOR COULD NOT BE INTERROGATED. A DIFFERENT GENERATOR WAS CHOSEN, INTERROGATED SUCCESSFULLY, AND IMPLANTED. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR