BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1132727 · Received August 21, 2008

    Report

    Report Number
    1644487-2008-01978
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THEY WERE DOING SURGERY FOR BATTERY CHANGE AND RECEIVED 7/LIMIT/HIGH ON A SYSTEMS TEST. IT WAS ASKED BY MANUFACTURER FOR THE SITE TO GET THE TEST RESISTOR PIN THAT WAS IN THE SAME PACKAGE AS THE NEW GENERATOR, REMOVE THE GENERATOR FROM THE PATIENT'S LEAD AND INSERT THE TEST RESISTOR. THE SITE MADE SURE THAT THEY INSERTED THE TEST RESISTOR PIN AND USED THE HEX SCREW DRIVER TO MAKE SURE IT WAS PROPERLY INSERTED, THE HEX SCREWDRIVER CLICKED TWICE. THE MANUFACTURER THEN HAD THEM RE-INTERROGATE THE GENERATOR AND RUN GENERATOR DIAGNOSTICS. THE GENERATOR DIAGNOSTICS RESULTED IN HIGH IMPEDANCE. THE SITE REPORTED THAT A SCREEN POPPED UP ON THE HANDHELD THAT SAID THE GENERATOR WAS NOT DELIVERING PROGRAMMED CURRENT AND TO MAKE SURE THE TEST RESISTOR WAS PROPERLY INSERTED. THE SITE REPORTED THAT THEY CLICKED PROCEED AND THE IMPEDANCE READ "HIGH". IT WAS CONFIRMED THAT THE TEST RESISTOR PIN WAS FULLY INSERTED. THE GENERATOR IS AT THE MANUFACTURER PENDING COMPLETION OF PRODUCT ANALYSIS. MANUFACTURE ADDRESSED THE HIGH LEAD IMPEDANCE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 016869

    Patients

    Seq Age Sex Outcome Treatment
    1