BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3751967 · Received April 15, 2014

    Report

    Report Number
    3004209178-2014-07286
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Report Date
    March 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V190606, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S DEVICE HAD ISSUES FOLLOWING A CHIROPRACTOR APPOINTMENT. IT WAS NOTED THE CHIROPRACTOR GOT TOO CLOSE TO THEIR DEVICE WITH A ¿ROTOR THING, A WHEEL THING.¿ IT WAS REPORTED THE ISSUE OCCURRED A YEAR PRIOR TO THE CALL. IT WAS NOTED REPROGRAMMING RESOLVED THE ISSUE. IT WAS REPORTED THE REPROGRAMMING WAS NECESSARY AS THEIR DEVICE WAS "NOT GETTING ANY SIGNALS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229323 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR