BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1242941 · Received November 21, 2008

    Report

    Report Number
    1644487-2008-02785
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 27, 2008
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT'S DEVICE WAS EXPLANTED DUE TO PAIN AND THAT THERE WERE NO PLANS FOR REPLACEMENT. FOLLOW-UP REVEALED THAT THE PATIENT HAS EXPERIENCED PAIN AROUND THE DEVICE IN THE NECK AND ON THE LEFT SIDE OF THE CHEST. THE RELATIONSHIP OF THE PAIN EVENT TO VNS THERAPY IS UNK AT THIS TIME. SEVERAL THERAPIES WERE TRIED TO RESOLVE THE PAIN BUT WERE UNSUCCESSFUL, THEREFORE, THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE AS A LAST OPTION. NO SPECIFIC DEVICE ISSUES WERE REPORTED. IT WAS INDICATED THAT THE PATIENT'S PAIN WAS CONSTANT AND EXISTENT EVEN WHEN THE GENERATOR WAS PROGRAMMED TO 0 MA. BOTH THE LEAD AND GENERATOR WERE EXPLANTED FROM THE PATIENT. GOOD FAITH ATTEMPTS TO OBTAIN PRODUCTS FOR PRODUCT ANALYSES HAVE BEEN UNSUCCESSFUL TO DATE. IT IS UNK AT THIS TIME IF THE PATIENT'S PAIN EVENT RESOLVED AFTER THE VNS DEVICE WAS EXPLANTED AS THE PATIENT HAS NOT FOLLOWED UP WITH THE NEUROLOGIST SINCE THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 012407

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention