BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4196258 · Received October 23, 2014

    Report

    Report Number
    3004209178-2014-20247
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V952323, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    WHEN THE ¿URGE HIT¿ THE PATIENT, THEY HAD TO STAND STILL AND CONTROL THEMSELVES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S STIMULATOR WAS NOT AS EFFECTIVE AS IT SHOULD BE. SOME DAYS WERE FINE AND OTHERS WERE LIKE BEFORE THEY GOT THE IMPLANT. PREVIOUSLY, THE PATIENT WALKED THROUGH A SECURITY GATE WITHOUT TURNING STIMULATION OFF AND FELT ¿VERY STIMULATED.¿ WHILE ON THE CALL, THE PATIENT WAS ABLE TO INCREASE STIMULATION TO A COMFORTABLE LEVEL. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675391 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1