BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3693602 · Received March 21, 2014

    Report

    Report Number
    3004209178-2014-04846
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 26, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT# V871805, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT SAW THE POWER ON RESET (POR) SCREEN PRIOR TO A BRAIN MRI. IT WAS NOTED THE PATIENT COULD NOT ADJUST STIMULATION. IT WAS REPORTED THE PATIENT SAW THE ¿CALL YOUR DOCTOR¿ ICON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170303 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR