BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL CORD STIMULATOR

    MDR report key: 1932623 · Received December 14, 2010

    Report

    Report Number
    MW5018598
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 14, 2010
    Manufacturer
    MEDTRONICS
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SPINAL STIMULATOR GENERATOR EXCHANGE REQUIRED AFTER 11 MONTHS OF USE. BATTERY REVISION OF THORACIC SPINAL CORD STIMULATOR AND RECHARGEABLE BATTERY - SHORT PROCEDURE (B)(6)2010. NOTE: ARRANGEMENTS ARE PENDING WITH MEDTRONICS TO RELEASE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL CORD STIMULATOR NONE LGW MEDTRONICS SN NKL712598H

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization