BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 2823417 · Received November 7, 2012

    Report

    Report Number
    1644487-2012-02923
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 8, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS IN THE HOSPITAL FOR LEFT SIDED HEMIPARALYSIS FOLLOWING VNS LEAD REPLACEMENT. THE PHYSICIAN INDICATED AT THE TIME OF THE REPORT THAT HE BELIEVES THIS WAS LIKELY A PSYCHOSOMATIC MANIFESTATION. A LATER REPORT FROM THE PATIENT INDICATED SHE WAS RECOVERING AND WAS NOT EXPERIENCING ANY PAIN AT THE LEAD OR GENERATOR. AN IMPLANT CARD WAS RECEIVED THAT INDICATED THE LEAD IMPEDANCE WAS "OK." ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304 LEAD LYJ CYBERONICS INC 304-20 3159

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| S