BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3183230 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10739
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V772374, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS REPLACED BECAUSE IT WAS THOUGHT THAT THE DEVICE WAS NOT WORKING PROPERLY BECAUSE THE PATIENT PROBABLY ¿SCREWED UP YOUR LEADS¿ WITH THERAPY ACTIVITIES THE PATIENT WAS INVOLVED IN FOR POLIO. IT WAS NOTED THAT A SECOND LEAD WAS IMPLANTED ALONG WITH REPLACING THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282612 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention