BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 3902616 · Received June 30, 2014

    Report

    Report Number
    1644487-2014-01630
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    January 6, 2003
    Report Date
    June 2, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS OF THE LEAD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ANALYSIS OF A GENERATOR EXPLANTED DUE TO END OF SERVICE WAS COMPLETED ON (B)(6) 2014. THE SUPPLY CURRENT 1 MA TEST DID NOT MEET FUNCTIONAL SPECIFICATION. THIS MEASUREMENT DEMONSTRATED AN INCREASED CURRENT CONSUMPTION ON THE BATTERY AND POTENTIALLY COULD CONTRIBUTE TO A PREMATURE END OF SERVICE CONDITION. ROOT CAUSE FOR THE INCREASE CURRENT CONSUMPTION IN THE SUPPLY CURRENT 1 MA MEASUREMENT WAS CONFIRMED TO BE THE C6 COMPONENT. THE REASON FOR THE C6 COMPONENT¿S INCREASE IN LEAKAGE CURRENT COULD NOT BE DETERMINED. AFTER THE C6 COMPONENT WAS SUBSTITUTED, THE MODULE LEVEL PULSE GENERATOR PERFORMED ACCORDING TO THE FUNCTIONAL SPECIFICATIONS. THE OUT-OF-LIMIT SUPPLY CURRENT 1 MA COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE DEPLETED BATTERY CONDITION; HOWEVER, RESULTS OF THE BATTERY LIFE CALCULATION INDICATED THAT THE END OF SERVICE CONDITION WAS AN EXPECTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380584 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS INC 101 7630

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR