BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2141117 · Received June 22, 2011

    Report

    Report Number
    1644487-2011-01397
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT THE PATIENT'S DEVICE WAS GOING TO BE REPLACED PROPHYLACTICALLY AS THE PATIENT WAS HAVING MORE SEIZURES THAN BEFORE SHE HAD VNS. FURTHERMORE, THE PATIENT WAS UNABLE TO FEEL STIMULATION, BUT SHE HAS HAD 2 OCCASIONS OF FEELING STIMULATION "CONTINUOUSLY". THE PATIENT'S CURRENT SETTINGS WERE 2.0 MA/30 HZ/250 MICROSEC/30 SEC/0.8 MINS, AND DIAGNOSTIC TESTING SHOWED THE DEVICE TO BE PROPERLY FUNCTIONING. THERE HAD BEEN NO RECENT STRESSORS OR CHANGES TO INDUCE THE INCREASE IN SEIZURES. FOLLOW-UP WITH THE PHYSICIAN INDICATED THAT THE CAUSE OF THE SEIZURES WAS A "FAILING" BATTERY IN THE VNS. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE PATIENT UNDERWENT A GENERATOR REPLACEMENT, AND THE EXPLANTED PRODUCT WAS RETURNED TO THE MANUFACTURER, ALTHOUGH IT HAS NOT BEEN EVALUATED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC. 102 014911

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention