BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1934467 · Received November 23, 2010

    Report

    Report Number
    3007566237-2010-09885
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    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 IMPEDANCE MEASUREMENTS OF THE PATIENT'S NEUROSTIMULATOR WERE <250 OHMS. ADDITIONAL INFO WAS REQUESTED.

    Devices

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

    Patients

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