BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1963484 · Received December 20, 2010

    Report

    Report Number
    3007566237-2010-10584
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 13, 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 DURING AN IMPLANT PROCEDURE THAT IMPEDANCES OF >4000 OHMS WERE MEASURED ON ALL OF THE BIPOLAR ELECTRODE PAIRS. THE NEUROSTIMULATOR AND THE LEAD WERE REPLACED. IMPEDANCES MEASURED AFTER THE REPLACEMENT WERE INITIALLY HIGH (>4000 OHMS), BUT RESOLVED AFTER INCREASING THE DEFAULT TEST VALUES TO 2 VOLTS AND 330 PW. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC NEUROMODULATION 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR EXPLANTED:| IMPLANTED:| LEAD: MODEL LEAD URO, LOT# UNK