BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 1033097 · Received April 22, 2008

    Report

    Report Number
    1644487-2008-00975
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Report Date
    March 27, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. ARTICLE: KOSTOV, H., LARSSON, P.G, ROSTE, G.K. "IS VAGUS NERVE STIMULATION A TREATMENT OPTION FOR PATIENTS WITH DRUG-RESISTANCE IDIOPATHIC GENERALIZED EPILEPSY?" ACTA NEUROLOGICA SCANDINAVIA 2007:115, PP. 55-58.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE 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) DUE TO AN UNSPECIFIED LEAD PROBLEM. ATTEMPTS HAVE BEEN MADE WITH THE PHYSICIAN TO OBTAIN ADD'L INFO, BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL UNKNOWN LYJ CYBERONICS, INC. 30X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other