BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING COMPUTER

    MDR report key: 3469202 · Received November 14, 2013

    Report

    Report Number
    1644487-2013-03484
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    October 15, 2013
    Report Date
    October 15, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PHYSICIAN TRIED TO DISABLE THE PATIENT'S DEVICE TO 0 MA; HOWEVER, WHEN HE PRESSED THE ZERO VALUE, THE HANDHELD DID NOT RESPOND TO THAT CHOICE. FOLLOW UP WITH THE PHYSICIAN FOUND THAT AFTER TROUBLESHOOTING WITH THE MANUFACTURER'S REPRESENTATIVE, THE PHYSICIAN WAS ABLE TO DISABLE THE DEVICE SO THE PATIENT COULD GET ECT THERAPY. THE PROGRAMMING SYSTEM WAS THEREFORE FUNCTIONING OKAY AND THE PATIENT'S DEVICE WAS ABLE TO BE PROGRAMMED. REVIEW OF THE HANDHELD DEVICE HISTORY RECORDS CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591131 PROGRAMMING COMPUTER PROGRAMMING COMPUTER LYJ CYBERONICS INC MODEL 250 868885

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR