BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1854039 · Received September 2, 2010

    Report

    Report Number
    1644487-2010-02007
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 3, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN EXPLANT FACILITY THAT A NEW GENERATOR WAS TO BE RETURNED TO THE MANUFACTURER DUE TO A "BAD BATTERY." EXPLANT NOTES FROM THE SURGEON INDICATED THE DEVICE WAS INITIALLY CHECKED "GOOD" AND THEN "FIRST CHECK AFTER THE PATIENT WAS CLOSED INDICATED BAD BATTERY." THE DEVICE WAS RETURNED TO THE MANUFACTURER AND UNDERWENT PRODUCT ANALYSIS. PROGRAMMING HISTORY WAS RECEIVED FROM THE SURGEON'S OFFICE INDICATING THE GENERATOR WENT FROM 10 YEARS TO 0 YEARS REMAINING AFTER AN INTERROGATION WAS PERFORMED. MOREOVER, PRODUCT ANALYSIS WAS COMPLETED BY THE MANUFACTURER ON THE RETURNED GENERATOR. PRODUCT ANALYSIS REVEALED THE END-OF-SERVICE WARNING MESSAGE WAS VERIFIED IN THE PRODUCT ANALYSIS LAB AND FOUND TO BE ASSOCIATED WITH THE OUTPUT BEING DISABLED BY THE PULSE GENERATOR. A ROOT CAUSE FOR THIS CONDITION COULD NOT BE DETERMINED. ONCE THE OUTPUT WAS RE-ENABLED, RESULTS OF ELECTRICAL TEST RESULTS DEMONSTRATED THAT THE PULSE GENERATOR WAS OPERATING WITHIN SPECIFICATION. OTHER THAN THE OUTPUT DISABLE CONDITION, THERE WERE NO ADDITIONAL ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. THE REPORTED EOS CONDITION WAS NOT DUPLICATED DURING THE PA ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2612

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR