BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4191060 · Received October 21, 2014

    Report

    Report Number
    3004209178-2014-20129
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Report Date
    September 29, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0EUA2, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S BOWELS CLOGGED UP AND NOW SHE HAD TO TAKE MEDICINE ALL THE TIME SO HER BOWELS DIDN¿T CLOSE UP. THE PATIENT TOLD HER REGULAR DOCTOR THAT SHE WAS HAVING A PROBLEM WITH HER BOWELS, SHE COULDN¿T GO TO THE BATHROOM, AND SHE STOPPED UP THE TOILET. THE DOCTOR GAVE HER A LAXATIVE. THE LAXATIVE WAS WORKING FOR HER AND KEPT HER BOWELS OPEN. THE PATIENT WAS GOING TO THE BATHROOM ALL THE TIME AND ¿ALL OVER AGAIN¿ AND SHE THOUGHT SHE HAD TURNED THE DEVICE UP TO 8. THIS HELPED SOME BUT HER BUTT HURT ¿LIKE A PULSE THING¿ WHEN THE DEVICE WAS ON. SHE FELT PULSATION THAT WAS ALWAYS HURTING BUT IT WASN¿T BAD UNTIL STIMULATION WAS INCREASED. IT WAS ALWAYS LIKE THAT, AND SHE¿D RATHER HURT HER BUTT A BIT AND GET SOME SLEEP INSTEAD OF GOING TO THE BATHROOM. SHE HAD BEEN GOING 12 TIMES AT NIGHT, NOW SHE WAS GOING 5 TIMES, AND SHE WAS ABLE TO GET SOME SLEEP. THE PATIENT SAID THAT SHE¿D RATHER HAVE IT DO THAT THAN GO TO THE DOCTOR 12 TO 13 TIMES. THE PATIENT DIDN¿T KNOW IF SHE HAD TRIED OTHER PROGRAMS. SHE WASN¿T SCHEDULED TO SEE HER DOCTOR UNTIL (B)(6). ADDITIONAL INFORMATION RECEIVED INDICATED ON (B)(6) 2014, THE DAY OF THIS CALL THAT PATIENT STIMULATOR WAS NOT WORKING. THE PATIENT HAD NEW BATTERIES IN AND WAS AT THE UPPER LIMIT OF 8.5, BUT WAS NOT FEELING ANY STIMULATION AT ALL. THE PATIENT STATED THAT USUALLY 8.5 WOULD BE SENDING SHOCKS THROUGH HER BUTT. THE PATIENT CONFIRMED STIM WAS TURNED ON AND AT 8.5. IT WAS ALSO MENTIONED ON THE DAY OF THIS CALL THAT PATIENT WAS GOING TO THE BATHROOM 6 TIMES AND SHE USED TO GO 4 TIMES WHICH STARTED ABOUT A MONTH AGO. THE PATIENT APPOINTMENT WAS SCHEDULED WITH THEIR MANAGING HEALTH CARE PROVIDER ON (B)(6) AND WOULD LIKE THE MANUFACTURER REPRESENTATIVE PRESENT. INFORMATION RECEIVED LATER INDICATED THAT PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WAS WORKING WITH HEALTH CARE PROVIDER OR MANUFACTURER REPRESENTATIVE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670356 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR