BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN STIMULATION LEAD

    MDR report key: 1000044 · Received February 15, 2008

    Report

    Report Number
    2182207-2008-00718
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE MFR REPRESENTATIVE REPORTED THE PT EXPERIENCED NUMBNESS AND SWELLING IN THE LEGS AFTER UNDERGOING TRIAL SURGERY. THE HCP AT THE CLINIC STATED THE PT HAS HIGH REFLEX, AND THINKS IT MIGHT BE AN EPIDURAL BLEED. A CT SCAN WILL BE CONDUCTED TO DIAGNOSE THE PROBLEM. ADD'L INFO 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 ADD'L INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN STIMULATION LEAD UNKNOWN GZB MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention