BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1850869 · Received September 28, 2010

    Report

    Report Number
    3007566237-2010-07379
    Event Type
    Injury
    Date Received
    September 28, 2010
    Report Date
    August 30, 2010
    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 THE PT, IMPLANTED WITH THIS LEAD, INDICATED LOSS OF STIMULATION AND EFFECTIVENESS. HIGH IMPEDANCE WAS MEASURED BY THE PHYSICIAN. AFTER LEAD REPLACEMENT STIMULATION WAS EFFECTIVE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW EZW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| LEAD: MODEL 3093, LOT # UNK| EXPLANTED: