BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 3698361 · Received March 25, 2014

    Report

    Report Number
    1644487-2014-00765
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    January 22, 2008
    Report Date
    February 24, 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

    ANALYSIS OF AN EXPLANTED GENERATOR WAS COMPLETED ON (B)(4) 2014. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS, WITH THE EXCEPTION OF THE BACKUP CAP POS TO CAN TEST. WITH AN EXTERNAL CAPACITOR (4.0NF) CONNECTED BETWEEN THE PULSE GENERATOR CASE AND POSITIVE OUTPUT, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR IS OPERATING ACCORDING TO FUNCTIONAL SPECIFICATIONS. THIS SHOWS THAT THE POSITIVE FEED-THRU CAPACITOR WAS ELECTRICALLY OPEN. THE MOST PROBABLE ROOT CAUSE FOR THE BACKUP CAP POS TO CAN TEST WAS IDENTIFIED TO BE AN OPEN CAPACITOR, WHICH MANIPULATION OF THE FEED-THRU WIRES MAY HAVE BEEN A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174927 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS INC 104 200699

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR