BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2211090 · Received August 5, 2011

    Report

    Report Number
    1644487-2011-01765
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HOSPITAL THAT DURING THE PT'S INITIAL IMPLANT SURGERY, THE GENERATOR'S SETSCREW WAS NOT ABLE TO BE TIGHTENED. THE SCREWDRIVER TURNED AROUND INSIDE OF THE HEADER, BUT A CLICKING NOISE WAS NOT HEARD, WHICH INDICATES THE SETSCREW HAS BEEN SUFFICIENTLY TORQUED. IT WAS NOT KNOWN IF ANOTHER SCREWDRIVER WAS USED. ANOTHER GENERATOR WAS OPENED AND WAS USED WITHOUT ISSUE. THE SUSPECT PRODUCT WAS RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 2790

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR