BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1961256 · Received January 11, 2011

    Report

    Report Number
    1644487-2011-00034
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    September 23, 2010
    Report Date
    December 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    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 A PT UNDERWENT GENERATOR REVISION SURGERY DUE TO AN INCREASE IN SEIZURES AND END OF SERVICE OF THE GENERATOR (DETERMINED BY THE OBSERVATION OF AN ERI = YES FLAG). THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER AND WHILE THE GENERATOR WAS FOUND TO NOT BE AT END OF SERVICE, AN ERI = YES FLAG WAS OBSERVED. THIS IS MOST LIKELY DUE TO PARTIAL DEPLETION OF THE BATTERY IN THE GENERATOR BASED ON A BATTERY LIFE CALCULATION AND ELECTRICAL TEST RESULTS. 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 THE AUTOMATED POST BURN-IN TEST. THIS OUT OF LIMIT SUPPLY CURRENT PULSING COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE ERI CONDITION OF THE BATTERY BUT THE ERI = YES WAS AN EXPECTED EVENT BASED ON THE BATTERY LIFE CALCULATION. FOLLOW UP WITH THE SITE REVEALED THAT THE SEIZURES HAVE DECREASED SINCE GENERATOR REPLACEMENT SURGERY. THE SEIZURES THE PT EXPERIENCED PRIOR TO GENERATOR REVISION WERE THOUGHT TO BE ABOVE PRE-VNS BASELINE LEVELS PER THE PT AND CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 5213

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention