BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3851361 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10175
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 16, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT# VA0AM2P, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED IN FOR HELP ADJUSTING HER DEVICE. THE PATIENT NOTED SHE GOT BEAUTIFUL RESULTS FOR A COUPLE MONTHS THEN SHE HAD TO GO INTO THE HOSPITAL FOR REASON UNRELATED TO HER DEVICE. THE PATIENT'S SYMPTOMS RETURNED WHEN SHE GOT HOME FROM THE HOSPITAL ABOUT A WEEK AGO. THE PATIENT COULD NOT GET HER DEVICE BACK TO THE PERFECT SETTING. THE PATIENT HAD IT NOTED THAT PROGRAM 3 WAS MOST EFFECTIVE. THE PATIENT'S STIM WAS ON AND SHE WAS ON PROGRAM 3. THE PATIENT INCREASED STIM TO 7.5V AND THE PATIENT WAS NOT ABLE TO FEEL STIM. REGARDING IF THE PATIENT HAD ANY FALLS OR TRAUMAS, IT WAS NOTED THAT THE PATIENT FELL 2 DAYS AGO. LAST NIGHT IN THE MIDDLE OF THE NIGHT THE PATIENT FELT A STRONG SENSATION IN HER RIGHT LEG AND WHEN LAID BACK DOWN "IT WAS STILL DOING IT". IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329968 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR