BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2050204 · Received April 1, 2011

    Report

    Report Number
    1644487-2011-00703
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 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 INITIALLY REPORTED BY THE ATTENDING NEUROLOGIST THAT DURING THE EXPLORATORY REVISION SURGERY FOR THE PT, THAT THE PULSE GENERATOR WAS SHOWING TO BE AT EOS. THE PT'S DEVICE WAS RECENTLY IMPLANTED, SO WAS NOT EXPECTED TO BE AT AN EOS CONDITION. THE PT'S REVISION SURGERY WAS UNRELATED TO THE GENERATOR AND NOT DUE TO ANY DEVICE MALFUNCTION OR PT SERIOUS EVENT, BUT WAS TO REMOVE THE TIE-DOWNS PLACED DURING THE INITIAL IMPLANT. IT WAS NOTED BY THE NEUROLOGIST THAT THE SURGEON DID USE ELECTROCAUTERY WHILE OPENING THE PT'S GENERATOR POCKET. THE NEUROLOGIST INDICATED THAT THE DEVICE WAS ABLE TO BE COMMUNICATED WITH PRIOR TO THE SURGERY. THE PULSE GENERATOR WAS REPLACED AT THAT TIME AND RETURNED TO THE MFR FOR ANALYSIS, WHICH HAS YET TO BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2762

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR