BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 2882636 · Received December 20, 2012

    Report

    Report Number
    1644487-2012-03432
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    October 24, 2008
    Report Date
    November 30, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHYSICIAN'S OFFICE THAT THE PATIENT HAD REPOSITIONING SURGERY FOR THE LEAD IN (B)(6) 2008 DUE TO MIGRATION OF THE ELECTRODES. IT WAS INDICATED THAT THE PATIENT WAS EXPERIENCING PAINFUL STIMULATION IN THE NECK SO THE REVISION WAS PERFORMED. IT WAS INDICATED THAT ABSORBABLE SUTURES WERE USED DURING THE INITIAL IMPLANT. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT'S PAIN WAS NOT RELATED TO THE VNS, BUT THE CAUSE WAS NOT SPECIFIED. IT WAS FELT TO POSSIBLY BE DUE TO VNS STIMULATION. IT WAS UNKNOWN IF ANY CONTRIBUTORY PROGRAMMING OR MEDICATION CHANGES PRECEDED THE ONSET OF THE PAIN. IT IS POSSIBLE THERE WAS PATIENT TRAUMA AND MANIPULATION OF THE VNS. THE LEAD REPOSITIONING SURGERY WAS NOT PERFORMED TO PRECLUDE A SERIOUS INJURY. THE LEAD TIE-DOWNS WERE SECURED WITH NON-ABSORBABLE SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 200772

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention