BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4173240 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19713
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 24, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# VA0GKJK, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY BUT WAS WORKING WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE. THE DEVICE SOMETIMES CAUSED PAIN AND SHE OFTEN DIDN¿T FEEL IT WAS WORKING.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT DID NOT FEEL STIMULATION. INCREASING STIMULATION RESULTED IN PAINFUL STIMULATION AND FELT LIKE THEY DID NOT ¿HAVE A TAMPON IN ALL THE WAY.¿ THE PATIENT HAD BEEN EXPERIENCING DIARRHEA EVERY DAY FOR TWO WEEKS. THE ISSUE OCCURRED MORE IN THE MORNING. THE PATIENT HAD ALSO EXPERIENCED A SUDDEN RETURN OF BOWEL LEAKAGE FOR AT LEAST A MONTH. THE PATIENT HAD FALLEN ON THEIR KNEES OVER A MONTH PRIOR TO CALL. NO INTERVENTIONS OR OUTCOME WERE 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
    656169 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR