BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3163283 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10174
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # V198619, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION HAD BEEN OFF AND IT WAS ¿NOT WORKING.¿ IT WAS STATED THAT ¿PART OF THE ELECTRODE WAS OUT.¿ IT WAS UNKNOWN WHEN ¿IT STOPPED WORKING.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263592 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR