BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3033477 · Received April 3, 2013

    Report

    Report Number
    1644487-2013-00904
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    July 1, 2012
    Report Date
    March 5, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PATIENT'S MOTHER TO HER PHYSICIAN THAT HER DAUGHTER WAS ALLERGIC TO THE METAL OF THE GENERATOR AND HAD VNS EXPLANTED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. FOLLOW-UP WITH THE NEUROLOGIST REFERRED THE PATIENT TO BE IMPLANTED WITH VNS WAS UNAWARE OF THIS EVENT AND HAD NO INFORMATION TO PROVIDE. HE DID NOT REFER HER FOR EXPLANT AND HAVE NOT SEEN THE PATIENT FOR YEARS. THE PATIENT HAS MOVED TO FLORIDA SINCE IMPLANT AND IT IS BELIEVED BY THE PHYSICIAN THAT THE PATIENT MAY HAVE BEEN EXPLANTED IN FLORIDA BUT HE DOES NOT KNOW WHO THEY WERE SEEING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPLANTED (B)(6) 2012 AND THE HOSPITAL THEY THE PATIENT WAS EXPLANTED AT BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137489 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 015227

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention