BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 2942017 · Received February 4, 2013

    Report

    Report Number
    1644487-2013-00279
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 9, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD HIS GENERATOR AND LEAD EXPLANTED. THE EXPLANTED PRODUCT HAD BEEN DISCARDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HAVING THEIR GENERATOR AND LEAD EXPLANTED FOR UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR EXPLANT WAS DUE TO THE TIE-DOWNS THAT SECURE THE LEAD WERE CAUSING THE PATIENT SOME DISCOMFORT. THE PATIENT HAS BEEN DISABLED FOR SEVERAL MONTHS AND HAS BEEN DOING WELL SO HE WOULD LIKE THE VNS REMOVED. THE PATIENT HAS A LOBECTOMY AND HAS BEEN SEIZURE FREE SINCE THAT TIME. THE PATIENT WAS TO HAVE SURGERY LAST WEEK BUT IT IS UNCLEAR AT THIS TIME IF THAT OCCURRED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46723 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 2329

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention