BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1993862 · Received February 11, 2011

    Report

    Report Number
    3007566237-2011-01066
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED ALL IMPEDANCE MEASUREMENTS WERE OUT OF RANGE. A REVISION WAS PERFORMED TO SEE IF THE STIMULATOR WAS NOT CORRECTLY CONNECTED. DURING THE REVISION, THE IMPEDANCES WERE CHECKED WITH AN EXTERNAL NEUROSTIMULATOR, AND THE IMPEDANCES WERE STILL OUT OF RANGE. THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW ONE. THE LEAD WAS BROKEN AND THE TINES WERE NOT REMOVED. THERE WAS NO PT INJURY, AND THE PT IS CURRENTLY UNDER THE TEST STIMULATION PHASE WITH THE NEW LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR EZW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD: MODEL 3889, LOT# 0203391011| EXPLANTED:| IMPLANTED: