BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3191287 · Received June 26, 2013

    Report

    Report Number
    1644487-2013-01896
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE PATIENT HEARD A ¿NOISE¿ FROM HER GENERATOR TWO WEEKS PRIOR, LIKE A ¿FIZZING SOUND¿ AND THAT AT THAT TIME HER BODY FELT ELECTRIFIED, LIKE ¿HER FINGER WAS IN A LIGHT SWITCH¿. IT WAS STATED THAT THE PROBLEM HASN¿T HAPPENED SINCE THIS ONE OCCURRENCE. THE PATIENT ALSO STATED THAT SHE HAD A SEIZURE LAST WEEK, BUT IT HAD BEEN A WHILE SINCE THE LAST ONE. ON (B)(6) 2013 THE PATIENT REPORTED THAT THE VNS ISN¿T WORKING. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 7.47 YEARS REMAINING UNTIL ERI=YES. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. THE PHYSICIAN LATER REPORTED THAT THE PATIENT IS FINE NOW; HE DID NOT PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291500 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 013620

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR