BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2032419 · Received March 25, 2011

    Report

    Report Number
    1644487-2011-00633
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    September 10, 2003
    Report Date
    February 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN REVIEW OF PATIENT'S PROGRAMMING HISTORY, IT WAS NOTED THAT A VNS PATIENT'S DEVICE WAS DISABLED ON (B)(6) 2003. FOLLOW-UP INFORMATION WAS OBTAINED FROM THE PATIENT'S PHYSICIAN AND IT WAS REVEALED THAT THE PATIENT HAD BEEN DISABLED DUE TO AN EPISODE OF LOSS OF CONSCIOUSNESS WITH MAGNET USE. HOWEVER, THE PATIENT'S STIMULATION WAS RE-ENABLED ON (B)(6) 2008, AND THERE HAD BEEN NO RECURRENCE OF THE EPISODES. THE GENERATOR WAS LATER REPLACED PROPHYLACTICALLY FOR AN UNRELATED REASON AND WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS, AND THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE. GOOD FAITH ATTEMPTS TO GAIN MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    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 30 YR Required Intervention