BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL

    MDR report key: 1858990 · Received October 5, 2010

    Report

    Report Number
    3007566237-2010-07611
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 8, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    A PATIENT HAD LOST SUFFICIENT STIMULATION. IMPEDANCE MEASUREMENTS WERE NOTED AS BEING "OK". X-RAYS REVEALED THAT THE LEADS WERE STILL IN THE CORRECT POSITION. A LEAD REVISION/REPLACEMENT WAS PERFORMED. UPON THE LEAD REVISION, AN INSTANCE WAS NOTED WHERE IT WAS FOUND THAT THE STYLET COULD NOT BE ADVANCED INTO THE LEAD. THE PATIENT'S OUTCOME WAS NOTED AS "OK." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL LGW MEDTRONIC NEUROMODULATION IPG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| LEAD: MODEL #3877, LOT #203450190| UNK CONVERSION TYPE: MODEL #LEADN, LOT #UNK| EXPLANTED:| IMPLANTED:| IMPLANTED: