BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3143244 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08565
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 14, 2013
    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
    MI, 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# V386130, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL OFF A BED IN HER CAMPER AND FOR THE LAST COUPLE OF MONTHS HER SYMPTOMS HAVE GOTTEN SEVERELY WORSE. THE PATIENT WAS UNABLE TO HOLD URINE AND SOME DAYS THE PATIENT WAS UNABLE TO SIT DOWN BECAUSE STIMULATION FELT LIKE SOMETHING WAS POKING HER. THE PATIENT SLEPT ON HER BACK AND REALLY HAD TO ADJUST HERSELF OR SHE GOT POKING WITH A NEEDLE, BUT THE POKING WAS NOT ELECTRICAL. IT WAS NOTED THAT THE WIRES FELT LIKE THEY WERE POKING THROUGH THE PATIENT¿S ¿VAGINA CHEEKS¿ AND THE PATIENT DID NOT FEEL LIKE THE WIRES WERE IN THE SAME SPOT AS WHEN THEY WERE IMPLANTED. FOR THE LAST SIX MONTHS, THE PATIENT HAD BEEN WEARING PANTY LINERS. IT WAS INDICATED THAT THE PATIENT HAD A PERSONAL TRAINER AND STARTED TO EXERCISE DOING YOGA MOVES. THE PATIENT HAD ADJUSTED PROGRAMS AND SETTINGS IN THE PAST AND WAS CURRENTLY ON PROGRAM 1 AT 2.2 V, BUT IT WAS UNCOMFORTABLE AND TOO STRONG. AT THE BEGINNING THE PATIENT WAS ON PROGRAM 4 AND IT WAS WORKING FINE; HOWEVER, THE PATIENT¿S DOCTOR CHANGED TO PROGRAM 1 BECAUSE THE PATIENT WAS HAVING TROUBLE. THE PATIENT SWITCHED TO PROGRAM 2 AT 2.5 V AND REPORTED THE SETTING WAS COMFORTABLE. THE PATIENT REQUESTED COMPATIBILITY GUIDELINES FOR MRI, AIRPORT SECURITY SCREENING DEVICES, AND PHYSICAL MOVEMENT. THE PATIENT WAS RECOMMENDED TO CONTACT HER DOCTOR TO HAVE THE DEVICE CHECKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244934 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1