BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL UNK

    MDR report key: 2921323 · Received January 17, 2013

    Report

    Report Number
    1644487-2013-00185
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    REPORTER INDICATED VIA THE MANUFACTURER'S IMPLANT CARD THAT A PATIENT HAD VNS LEAD REIMPLANTATION SURGERY ON (B)(6) 2012 FOLLOWING AN INFECTION. THE EXPLANT DATE OF THE PREVIOUS LEAD IS UNKNOWN. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26914 LEAD MODEL UNK LEAD MUZ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention