BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2993202 · Received March 7, 2013

    Report

    Report Number
    1644487-2013-00632
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    December 1, 2012
    Report Date
    February 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT'S GENERATOR WAS UNABLE TO BE INTERROGATED, AND IT COULD NOT BE DETERMINED IF THE ISSUE WAS WITH THE PROGRAMMING WAND OR THE PATIENT'S VNS AS THE REPORTER HAS ONLY ONE VNS PATIENT TO TEST THE PROGRAMMING WAND WITH. THE PROGRAMMING SYSTEM WAS REPORTED TO "HAVE NOT BEEN WORKING" FOR A FEW MONTHS. THE WAND BATTERY WAS SUSPECTED OF BEING DEPLETED, AS THE WAND BATTERY INDICATOR LIGHT DID NOT ILLUMINATE. A BATTERY LIFE ESTIMATE PERFORMED BY THE MANUFACTURER YIELDED 3.25 YEARS REMAINING, HOWEVER; NEARLY 6 YEARS OF PROGRAMMING HISTORY IS MISSING. DEVICE HISTORY RECORD REVIEW FOR THE WAND AND GENERATOR CONFIRMED BOTH DEVICES MET ALL FINAL TESTING PRIOR TO DISTRIBUTION. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT'S VNS GENERATOR WAS ABLE TO BE SUCCESSFULLY INTERROGATED ON (B)(6) 2013 FOLLOWING REPLACEMENT OF THE 9 VOLT BATTERY IN THE REPORTER'S VNS PROGRAMMING WAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97824 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 13620

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR