BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1336465 · Received March 6, 2009

    Report

    Report Number
    1644487-2009-00459
    Event Type
    Injury
    Date Received
    March 6, 2009
    Date of Event
    January 1, 2001
    Report Date
    February 10, 2009
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LE, H, ET AL, INTRASCAPULAR PLACEMENT OF A VAGAL NERVE PULSE GENERATOR FOR PREVENTION OF WOUND TAMPERING. 2006;36:164-166.

    Description of Event or Problem · 1

    IN REVIEW OF AN ARTICLE, IT WAS NOTED THAT A COGNITIVELY DELAYED VNS PT WHO HAD THEIR PULSE GENERATOR PLACED IN THE SUBCLAVICULAR REGION EXPERIENCED WOUND BREAKDOWN AND SECONDARY INFECTION. THE AUTHOR INDICATES THAT THE EVENTS WERE DUE TO RELENTLESS TAMPERING OF THE WOUND. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR 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 Other