BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1171213 · Received September 22, 2008

    Report

    Report Number
    3004209178-2008-05993
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    January 1, 2007
    Report Date
    August 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD ABDOMINAL STIMULATION THREE DAYS POST IMPLANT. AN X-RAY SHOWED SLIGHT LEAD MIGRATION OF THE LEAD. THE LEAD WAS REPLACED AND PULLED DOWN 1/2 VERTEBRAL BODY FROM THE PREVIOUS LEAD POSITION. POST REPLACEMENT, THE PT CONTINUED TO ONLY FEEL ABDOMINAL STIMULATION. ADD'L INFO RECEIVED INDICATED THE PT ALSO EXPERIENCED HEATING IN THE PUMP POCKET AND CHOSE TO TURN OFF THE DEVICE. ADD'L PROBLEM SOLVING WITH THE DEVICE RESULTED IN NO CHANGES IN STIMULATION AND THEREFORE THE ENTIRE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION MODEL 37083 LOT# NKC012410N| IMPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 37742 LOT# NJD057752N| EXPLANTED| EXTENSION MODEL 37083 LOT# NKC013194N| EXPLANTED| LEAD MODEL 3998 LOT# V050371