BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 3813449 · Received May 15, 2014

    Report

    Report Number
    1644487-2014-01277
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    January 19, 2001
    Report Date
    April 17, 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 FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A GENERATOR THAT WAS EXPLANTED DUE TO NORMAL END OF SERVICE WAS RETURNED FOR ANALYSIS WHICH WAS COMPLETED ON (B)(4) 2014. SUPPLY CURRENT PULSING WAS OUT-OF-SPECIFICATION ON THE CURRENT AUTOMATED POST BURN TEST. ANALYSIS INDICATED THAT DURING MANUFACTURE OF THE GENERATOR, THE R35 RESISTOR (A SELECTABLE VALUE RESISTOR) COULD HAVE BEEN MORE OPTIMALLY CHOSEN. A LOWER VALUE RESISTOR WOULD HAVE MORE SUITABLY CENTERED THE CURRENTS WITHIN THEIR LIMITS. AFTER R35 WAS OPTIMALLY RESELECTED, THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE OUT-OF-SPECIFICATION SUPPLY CURRENT PULSING COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE END OF SERVICE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290520 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS INC 101 1933

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR