BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4241232 · Received November 10, 2014

    Report

    Report Number
    1644487-2014-02979
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 13, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEAD REPLACEMENT SURGERY FOR PATIENT MANIPULATION TO THE LEAD, THE SET SCREW OF THE GENERATOR COULD NOT BE TIGHTENED; THEREFORE, THE GENERATOR WAS ALSO REPLACED. THE SURGEON INDICATED THAT THE SCREWDRIVER FROM NEW GENERATOR WAS USED AND THE SETSCREW WOULD NOT CATCH ON ANY THREAD. THE EXPLANTING FACILITY WILL NOT RETURN EXPLANTED DEVICES WITHOUT PATIENT CONSENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724061 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS INC 105 3909

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR