BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3373238 · Received September 27, 2013

    Report

    Report Number
    3004209178-2013-17074
    Event Type
    Malfunction
    Date Received
    September 27, 2013
    Report Date
    September 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-33, LOT# V941222, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED IN (B)(6) 2012 AND THEIR STIMULATION HAD WORKED WELL IN CONTROLLING THEIR SYMPTOMS OF CONSTIPATION. IT WAS STATED THAT IN (B)(6) 2013, THE PATIENT HAD A TWO LEVEL SPINAL FUSION AND SINCE THEN THEY HAD A RETURN OF SYMPTOMS OF CONSTIPATION. IT WAS NOTED FOR THE LAST THREE WEEKS PRIOR TO REPORT THE PATIENT HAD TO TAKE PERICOLACE, A STOOL SOFTENER WITH A LAXATIVE, AND THAT DIDN¿T WORK SO WELL. IT WAS STATED (B)(6) TABS WORKED FOR THE PATIENT BUT WERE PAINFULLY UNCOMFORTABLE AND MAKES THEM ¿CRAMPY.¿ IT WAS ALSO REPORTED THE PATIENT HAD A HORRIBLE FALL IN (B)(6) AND HAD A CONCUSSION. IT WAS NOTED AT THE TIME OF REPORT THE PATIENT WAS ON PROGRAM 2 AND INCREASED THEIR STIMULATION FROM 1.8 TO 2.5 VOLTS AND STATED THEY FELT STIMULATION AND WOULD LEAVE IT THERE TO TRACK THEIR SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491011 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR