BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2143017 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04733
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 29, 2011
    Report Date
    May 30, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEADS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION ((B)(4) 2010).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT INTERROGATION IMPEDANCES WERE >4000. BECAUSE, THE DEVICE WAS WORKING PROPERLY, THE PHYSICIAN BELIEVED THE HIGH IMPEDANCES WERE DUE TO EXCESS FIBROSIS. DURING EXPLANT, THE LEAD BROKE AND THE DISTAL PORTION OF THE LEAD REMAINED IN THE BODY OF THE PT. A REPLACEMENT LEAD WAS IMPLANTED. 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 Required Intervention IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT# UNK