BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2130286 · Received June 13, 2011

    Report

    Report Number
    3007566237-2011-04346
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    June 3, 2010
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    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

    IT WAS REPORTED THAT ON (B)(6) 2010, THE #2 ELECTRODE ON THE LEAD WAS FRACTURED. ABOUT (B)(6) LATER, THE #0, #2, AND #3 WERE FRACTURED. ABOUT (B)(6) AFTER THAT, ALL ELECTRODES WERE FRACTURED. THE PT WAS REIMPLANTED ON (B)(6) 2010. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE NEUROSTIMULATOR EZW MEDTRONIC NEUROMODULATION IPG URO NA

    Patients

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