BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1033149 · Received April 22, 2008

    Report

    Report Number
    1644487-2008-00977
    Event Type
    Injury
    Date Received
    April 22, 2008
    Report Date
    March 27, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE: KOSTOV H., LARSSON, P.G., ROSTE, G.K. "IS VAGUS NERVE STIMULATION A TREATMENT OPTION FOR PTS WITH DRUG-RESISTANCE IDIOPATHIC GENERALIZED EPILEPSY?" ACTA NEUROLOGICA SCANDINAVIA 2007:115, PP.55-58.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR IN AN ARTICLE REVIEWED, THAT A VNS PT IN THE STUDY HAD TO BE RE-OPERATED DUE TO COMPLICATIONS FROM SURGERY (ASSUMING IMPLANT SURGERY) GENERATOR MIGRATION. ATTEMPTS HAVE BEEN MADE WITH THE PHYSICIAN TO OBTAIN INFO, BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK LYJ CYBERONICS, INC. 10X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other