BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6000153-2007-04557

    MDR report key: 968715 · Received December 20, 2007

    Report

    Report Number
    6000153-2007-04557
    Event Type
    Injury
    Date Received
    December 20, 2007
    Report Date
    November 21, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZB
    PMA / PMN Number
    K971756
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED A LOSS OF THERAPEUTIC EFFECT. THE PT BEGAN EXPERIENCING A BURNING SENSATION AND NUMBNESS APPROXIMATELY THREE MONTHS AGO. THE PATIENT STATED THE DEVICE HAS NEVER WORKED ON THE RIGHT SIDE AND LEAD MIGRATION WAS CONFIRMED BY X-RAY/FLUOROSCOPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY MEDTRONIC FROM THE HEALTH CARE PROFESSIONAL REGARDING THE REPORTED EVENT. A SUPPLEMENTAL MDR FOLLOW-UP REPORT WILL BE SENT TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GZB MEDTRONIC PUERTO RICO OPERATIONS CO. 3998 V011457

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention IMPLANTABLE NEUROSTIMULATOR MODEL 37711| EXPLANTED| LOT # NJH711933H