BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2210384 · Received August 8, 2011

    Report

    Report Number
    1644487-2011-01802
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    January 15, 2003
    Report Date
    July 12, 2011
    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 INITIALLY REPORTED THAT THE PT HAD A GENERATOR REPLACEMENT PROCEDURE DUE TO END OF SERVICE. THE GENERATOR WAS EXPLANTED AND RETURNED TO THE MFR FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS CONFIRMED THAT THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS SET TO YES, AND THAT THE BATTERY WAS PARTIALLY DEPLETED. THE AUTOMATED POST BURN-IN TEST SPECS WERE NOT MET, AS THE SUPPLY CURRENT 1MA MEASUREMENT WAS OVER THE LIMIT. BENCH ANALYSIS DETERMINED THAT Q9 HAD LEAKY CURRENT AND WAS THE ROOT CAUSE OF THE FAILURE. WHEN Q9 WAS REPLACED WITH A KNOWN GOOD BENCH COMPONENT, THE DEVICE MET THE SPECS REQUIREMENTS. IT WAS DETERMINED THAT THE LEAKY Q9 COMPONENT COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE END OF SERVICE CONDITION, INDICATING THAT THE DEVICE MAY HAVE REACHED END OF SERVICE PREMATURELY. A BATTERY LIFE CALCULATION PERFORMED DURING PRODUCT ANALYSIS INDICATED 0.75 YEARS REMAINING UNTIL THE ERI FLAG SHOULD BE SET TO YES. THE DEVICE DHR WAS REVIEWED AND THE GENERATOR PASSED ALL ELECTRICAL AND MECHANICAL TESTS, AS WELL AS FINAL QC INSPECTIONS PRIOR TO SHIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 7630

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR