BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1180454 · Received September 26, 2008

    Report

    Report Number
    1644487-2008-02342
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS EXPERIENCING PAIN AT THE GENERATOR IMPLANT SITE DURING DEVICE STIMULATION. THE PHYSICIAN INJECTED AREA WITH BOTOX WHICH RESOLVED THE PATIENT'S PAIN. GOOD FAITH ATTEMPTS TO OBTAIN PT AND PRODUCT INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention