BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1210756 · Received October 21, 2008

    Report

    Report Number
    1210756
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH CHRONIC BACK AND LEFT LOWER EXTREMITY PAIN (LUMBAR NERVE DISORDER, LUMBAR SPINAL STENOTIS AND LUMBAR NEURALGIA) AND IMPLANTATION OF PERMANENT SPINAL CORD STIMULATOR AND PULSE GENERATOR IN 2007. THIS FOLLOWED A SUCCESSFUL TRIAL OF SCS IN 2007. THE PULSE GENERATOR WAS UNABLE TO MAINTAIN A CHARGE AND THUS WAS REPLACED IN '08.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PULSE GENERATOR LGW MEDTRONIC INC. RESTORE 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization