BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1040550 · Received May 9, 2008

    Report

    Report Number
    1644487-2008-01112
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 10, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT CORRECTIVE SURGERY DUE TO A GENERATOR MIGRATION. PER THE SURGEON, IT WAS VISUALLY NOTED THAT A SUTURE WAS UTILIZED DURING THE INITIAL IMPLANT PROCEDURE TO SECURE THE GENERATOR TO FASCIA. CAUSE FOR MIGRATION REMAINS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization