BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1760636 · Received July 14, 2010

    Report

    Report Number
    1644487-2010-01624
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT WAS SCHEDULED FOR RE-IMPLANT SURGERY DUE TO UNKNOWN REASON. MOREOVER, FURTHER INFORMATION WAS RECEIVED FROM THE EXPLANTING FACILITY INDICATING THE PATIENT HAD UNDERGONE GENERATOR REPLACEMENT SURGERY DUE TO GENERATOR MIGRATION WHICH CAUSED THE PATIENT PAIN. AT THE MOMENT, GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE MIGRATION AND PAIN EVENTS HAVE BEEN UNSUCCESSFUL TO DATE. HOWEVER, THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER AND CURRENTLY UNDERGOING PRODUCT ANALYSIS.

    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 22 YR Required Intervention