BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2964329 · Received February 15, 2013

    Report

    Report Number
    1644487-2013-00420
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    END OF SERVICE MESSAGE SEEN UPON INTERROGATION OF THE PULSE GENERATOR.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT WHILE IMPLANTED A NEW GENERATOR DIAGNOSTICS INDICATED EOS=YES. ELECTROCAUTERY WAS USE DURING THE SURGERY BUT NOT WHILE THE GENERATOR WAS IN THE STERILE FIELD. A COMPANY REPRESENTATIVE WAS PRESENT AT THE SURGERY AND DID NOT WITNESS ANY CAUTERY BEING USED NEAR THE GENERATOR AND THE GENERATOR WAS NOT PLACED IN TO THE STERILE FIELD UNTIL AFTER THE CAUTERY WAS REMOVED. THE GENERATOR WAS NOT IMPLANTED AND A BACK-UP GENERATOR WAS IMPLANTED INSTEAD. THE NEW GENERATOR WHICH WAS SHOWING EOS=YES WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN 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. ONCE THE OUTPUT WAS RE-ENABLED, RESULTS OF ELECTRICAL TEST RESULTS DEMONSTRATED THAT THE PULSE GENERATOR WAS OPERATING WITHIN SPECIFICATION. RESULTS OF DIAGNOSTIC TESTING INDICATED THE DEVICE WAS OPERATING PROPERLY. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 2.841% OF THE BATTERY HAD BEEN CONSUMED. BURN MARKS WERE ALSO OBSERVED ON THE PULSE GENERATOR CAN, WHICH INDICATED THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68660 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 3202

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR