BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2102378 · Received May 20, 2011

    Report

    Report Number
    3007566237-2011-03716
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    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 IMPEDANCES WERE >4000 OHMS ON ALL UNIPOLAR PAIRS. COMPANY REP STATED THAT AN X-RAY WAS TAKEN AND THE LEAD APPEARED TO HAVE PULLED OUT OF THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PHYSICIAN WAS GOING TO GO IN AND TEST BOTH LEAD AND INS AND REPLACE COMPONENTS AS NECESSARY. THE PT'S STATUS WAS UNDETERMINED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 EXPLANTED:| LEAD: MODEL LEAD URO, LOT# UNK| IMPLANTED: