BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1033099 · Received April 22, 2008

    Report

    Report Number
    1644487-2008-00979
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    December 1, 2007
    Report Date
    April 3, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR THAT THE VNS PT HAD THEIR GENERATOR REPLACED DUE TO END OF SVC. THE EXPLANTED GENERATOR WAS SUBSEQUENTLY RETURNED TO MFR FOR ANALYSIS. ANALYSIS OF THE GENERATOR REVEALED THAT THE GENERATOR WOULD NOT COMMUNICATE IN THE AS-REC'D CONDITION, THEREFORE, THE GENERATOR WAS OPENED AND AN ANALYSIS WAS PERFORMED ON THE BATTERY AND PRINTED CIRCUIT BOARD ASSEMBLY. ANALYSIS VERIFIED THAT THE BATTERY WAS DEPLETED AND THAT THE DEVICE WAS AT THE END-OF LIFE. THE VOLTAGE DROP ACROSS THE SERIES RESISTOR INDICATED NORMAL DRAIN CURRENT OF THE DEVICE. A POST BURN-IN ELECTRICAL TEST WAS SUCCESSFULLY COMPLETED. A TEST SPEC REQUIREMENT WAS NOT MET AS THE SUPPLY PULSING CURRENT WAS FOUND TO BE OUT-OF-SPEC. FURTHER ANALYSIS SHOWED THAT Q9 AND Q10 TRANSISTORS HAD LEAKY CURRENT AND WAS THE ROOT CAUSE OF THE FAILURE. Q9 AND Q10 WERE REPLACED WITH KNOWN GOOD BENCH COMPONENTS. AFTER Q9 AND Q10 WERE REPLACED, A POST BURN-IN ELECTRICAL TEST WAS PERFORMED AND THE TEST SPECS WERE MET. ANALYSIS FOUND THAT THE DEFECTIVE Q9 AND Q10 DID NOT IMPACT DEVICE PERFORMANCE. THE POST BURN-IN ELECTRICAL TEST OUT-OF-SPEC SUPPLY PULSING CURRENT MEASUREMENT REPRESENTS A CONDITION THAT WOULD LIKELY HAVE A MINIMAL IMPACT ON THE BATTERY LONGEVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 5213

    Patients

    Seq Age Sex Outcome Treatment
    1