BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 3940931 · Received July 17, 2014

    Report

    Report Number
    1644487-2014-01809
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2002
    Report Date
    June 19, 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 MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO END OF SERVICE. ADDITIONALLY, THE PATIENT WAS HAVING SOME DISCOMFORT WHEN SYSTEM DIAGNOSTIC TESTS WERE PERFORMED. SURGERY WAS PERFORMED FOR PATIENT COMFORT AND NOT TO PRECLUDE A SERIOUS INJURY. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. AN OPEN CAN MEASUREMENT OF THE BATTERY VOLTAGE DETERMINED THAT THE GENERATOR BATTERY WAS DEPLETED. THE END OF SERVICE CONDITION WAS THE RESULT OF EXPECTED BATTERY DEPLETION BASED ON THE BATTERY LIFE CALCULATION. SUPPLY CURRENT PULSING AND SUPPLY CURRENT 1MA WERE OUT-OF-SPECIFICATION. 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; HOWEVER, RESULTS OF THE BATTERY LONGEVITY CALCULATION INDICATED THAT THE END-OF-SERVICE CONDITION WAS AN EXPECTED EVENT. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420435 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS INC 101 6350

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR