BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3800932 · Received May 8, 2014

    Report

    Report Number
    1644487-2014-01227
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    July 11, 2006
    Report Date
    April 11, 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

    THE GENERATOR WAS FOUND TO HAVE A LEAKY CAPACITOR, POTENTIALLY CONTRIBUTING TO A PREMATURE END OF SERVICE CONDITION.

    Description of Event or Problem · 1

    ANALYSIS OF A GENERATOR EXPLANTED FOR END OF SERVICE WAS COMPLETED ON (B)(4) 2014. THE SUPPLY CURRENT TESTS DID NOT MEET FUNCTIONAL SPECIFICATIONS. THESE MEASUREMENTS DEMONSTRATE AN INCREASED CURRENT CONSUMPTION FOR THE DEVICE, POTENTIALLY CONTRIBUTING TO A PREMATURE END OF LIFE CONDITION. THE INCREASED CURRENT CONSUMPTION WAS ISOLATED TO A LEAKY CAPACITOR (C4). A BATTERY LIFE ESTIMATION RESULTED IN 0.48 YEARS REMAINING BEFORE THE ERI FLAG WOULD BE SET. HOWEVER, AN INCOMPLETE PROGRAMMING HISTORY INDICATES THE ESTIMATION DOES NOT USE ALL THE DATA REQUIRED TO MAKE AN ACCURATE ESTIMATION. WITH THE CAPACITOR SUBSTITUTION FOR C4, THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE FOR THE PREMATURE END OF LIFE CONDITION WAS IDENTIFIED TO BE A LEAKY CAPACITOR, C4. THE CAUSE FOR THE C4 CAPACITORS INCREASE IN LEAKAGE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277531 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS INC 102R 015709

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR