BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3871839 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11544
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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# VA0HMVF, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT SINCE THE DAY PRIOR TO REPORT THE PATIENT¿S SYMPTOMS RETURNED AND THEY HAD 2 ACCIDENTS AND HAD A PROBLEM OF PASSING GAS. IT WAS NOTED THE PATIENT WAS NOT SURE IF THEY ATE ANYTHING THAT CAUSED IT. REPORTEDLY, THE PATIENT USED TO BE AT 1.5-1.6 VOLTS AND THEY TURNED IT UP TO 2 VOLTS AND FELT THE STIMULATION WAS NOT COMFORTABLE. THE PATIENT STATED ¿IT PINCHES¿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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND HAD HAD DIARRHEA SINCE YESTERDAY. IT WAS NOTED THAT THE PATIENT HAD AN X-RAY ON THEIR KNEE AND HAD FALLEN DOWN 2 WEEKS AGO. THE PATIENT WAS ON PROGRAM 3 AT 2.3V AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON. IT WAS REPORTED THAT THE PATIENT WANTED TO INCREASE STIMULATION TO SEE IF IT HELPED WITH THE DIARRHEA AND INCREASED TO 3.2V. THE PATIENT WAS NOT FEELING ANY STIMULATION AND THEY USUALLY DID. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. AN APPOINTMENT DATE OF (B)(6) 2014 WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351044 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR