BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1944299 · Received December 6, 2010

    Report

    Report Number
    3007566237-2010-10227
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCE MEASUREMENTS OF > 4000 OHMS WERE SEEN ON ALL COMBINATIONS WITH ELECTRODE 3. THE PT WAS REPROGRAMMED WHICH RESOLVED THE HIGH IMPEDANCE ISSUE. NO PT INJURIES WERE REPORTED.

    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 19 YR IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT# 0203356994