BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL

    MDR report key: 1801182 · Received August 11, 2010

    Report

    Report Number
    3007566237-2010-06028
    Event Type
    Injury
    Date Received
    August 11, 2010
    Report Date
    July 15, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A LEAD REVISION WAS REPORTED. THE LEAD HAD MIGRATED DUE TO A FAULTY "TITAN" ANCHOR. BOTH THE LEAD AND THE ANCHOR WERE REPLACED. THE PT'S STATUS WAS NOT REPORTED. 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 MHY MEDTRONIC NEUROMODULATION IPG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL TITAN ANCHOR, LOT# UNK