BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 1434691 · Received August 6, 2009

    Report

    Report Number
    MW5012276
    Event Type
    Malfunction
    Date Received
    August 6, 2009
    Date of Event
    July 28, 2009
    Report Date
    July 28, 2009
    Manufacturer
    REP - WILL LALLY
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED WITH A FAILED MEDTRONIC SPINAL CORD STIMULATOR. PATIENT WAS BROUGHT TO THE OPERATING ROOM AND THE GENERATOR WAS REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC RESTORE SPINAL CORD STIMULATOR LGW REP - WILL LALLY

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other