BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5216923 · Received November 11, 2015

    Report

    Report Number
    3004209178-2015-22593
    Event Type
    Injury
    Date Received
    November 11, 2015
    Report Date
    November 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0MN9K, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT "NEVER" HAD THERAPEUTIC EFFECT, STATING THAT THE DEVICE "HADN'T WORKED VERY WELL" SINCE IMPLANT. SINCE IMPLANT, THE PATIENT HAD NOT ATTENDED ANY FOLLOW-UP APPOINTMENTS. THE PATIENT WANTED THE DEVICE REPLACED, HOWEVER NO SURGERY WAS PLANNED. INDICATIONS FOR USE INCLUDED URINARY DYSFUNCTION AND GASTROINTESTINAL/PELVIC FLOOR. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE PATIENT MET WITH TWO HEALTHCARE PROVIDERS (HCP). STIMULATION WAS TURNED OFF ONE MONTH AGO AS IT WAS NOT HELPING AND THE PATIENT COULD NOT FIND ANOTHER HCP TO HELP MANAGE THE DEVICE. THE IMPLANT REPORTEDLY "GREATLY AFFECTED HER LIFE," AS THE PATIENT COULD NOT PEE OR HAVE SEX BECAUSE SHE WAS "MESSED UP DOWN THERE AND SHE CAN'T DO NOTHING RIGHT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748969 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Other