BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2439420 · Received February 6, 2012

    Report

    Report Number
    1644487-2012-00293
    Event Type
    Injury
    Date Received
    February 6, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 19, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WOULD BE UNDERGOING RADIATION THERAPY FOR THE TREATMENT OF CANCER. THE INITIAL REPORTER DID NOT KNOW THE TYPE OF CANCER THE PATIENT HAD OR ITS RELATIONSHIP TO VNS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL AS THE PATIENT'S PREVIOUS PHYSICIAN HAS NOT SEEN THE PATIENT IN A NUMBER OF YEARS AND WOULD NOT BE ABLE TO COMMENT ON THE CANCER AND THERE IS NO KNOWN CURRENT PHYSICIAN FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 GENERATOR MUZ CYBERONICS, INC. 101 2209

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention