BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1336464 · Received March 6, 2009

    Report

    Report Number
    1644487-2009-00460
    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 VNS PT WHO WAS DEEMED PRONE TO SCRATCHING HIS WOUND UNDERWENT INTERSCAPULAR PLACEMENT OF THE GENERATOR. HE SUBSEQUENTLY EXPERIENCED DELAYED HEALING OF THE WOUND WITHOUT ANY EVIDENCE OF HARDWARE INFECTION OR NEED FOR REMOVAL. THE AUTHOR INDICATES THAT THE PATIENT'S OBSESSIVE TAMPERING WITH THE WOUND LED HIM TO USE A WALL IN HIS HOME FOR SCRATCHING HIS BACK. THE PT HAD TO BE PLACED IN A JOBST VEST FOR WOUND PROTECTION.

    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