BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2955615 · Received February 11, 2013

    Report

    Report Number
    1644487-2013-00364
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    October 24, 2004
    Report Date
    January 14, 2013
    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. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAS A GENERATOR REPLACEMENT. THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND PRODUCT ANALYSIS WAS COMPLETED. 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. A BATTERY LIFE ESTIMATION RESULTED IN 2.22 YEARS REMAINING BEFORE THE NEOS FLAG WOULD BE SET. HOWEVER, AN INCOMPLETE PROGRAMMING HISTORY INDICATES THE ESTIMATION DOES NOT USE ALL THE DATA REQUIRED TO MAKE AN ACCURATE ESTIMATION. THE INCREASED CURRENT CONSUMPTION WAS ISOLATED TO A LEAKY CAPACITOR (C6). WITH THE CAPACITOR SUBSTITUTION FOR C6, 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 (C6). CAUSE FOR THE CAPACITORS (C6) INCREASE IN LEAKAGE COULD NOT BE DETERMINED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59920 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS INC 102R 011406

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR