BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3232353 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11911
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 24, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT # VA01R0X, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED AN MRI, X-RAY OR CT SCAN WAS DONE ON (B)(6)-2013 AND IT SHOWED THE LEADS WERE IN PROPER POSITION. IT WAS REPORTED THE PATIENT¿S DEVICE WAS REMOVED AT THE PATIENT¿S REQUEST. IT WAS NOTED THE PATIENT HAD LEG PAIN AND DID NOT REQUIRE HOSPITALIZATION. IT WAS STATED A BLADDER TUMOR WAS NOTED ON THE CYSTOSCOPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WITH LOSS OF BLADDER CONTROL. IT WAS NOTED THAT STIM TURNS OFF BY ITSELF. WHEN STIM IS ON, IT PUT TOO MUCH PRESSURE ON HER VAGINA AND FEELS SHE IS SWOLLEN INSIDE. THE PATIENT HAD PROBLEMS URINATING AND WAS RETAINING URINE. WHEN THE PATIENT TRIED TO URINATE, JUST DROPS CAME OUT. PT STATES INS WORKED GREAT AT FIRST 3 YEARS. BUT THIS LAST YEAR WAS WHEN SHE STARTED HAVING THE ISSUES. PT STATES THE PATIENT HAD BEEN IN THE ER 3 TIMES IN THE LAST MONTH. THE PATIENT COULD NOT REMEMBER EXACT DATES BUT THE LAST TIME WAS ON 6/20/13. THE PATIENT WENT IN BECAUSE SHE WAS HAVING A LOT OF PAIN IN LOWER BACK AND COULDN'T URINATE AT ALL. THE PATIENT COULDN'T DRINK WATER. THE PATIENT FELT LIKE EVERYTHING WAS HELD INSIDE HER BODY. THE HCP (HEALTHCARE PROVIDER) PUT IN A CATHETER FOR 3-4 DAYS AND WAS DOING OK. ONCE THEY TOOK IT OUT, SHE COULDN'T DO ANYTHING. EACH TIME THE PATIENT WENT TO THE ER, THEY PUT IN A CATHETER AND GAVE HER ANTIBIOTICS FOR THE PAIN. THE PATIENT DID HAVE SOMEONE PROGRAM IT FOR HER. THE HCP TOLD THE PATIENT TO CONTACT THE MANUFACTURER FOR REPROGRAMMING. THE PATIENT HAD NOT MADE ANY ADJUSTMENTS WITH THE PROGRAMMER. THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA. IT WAS NOTED STIM TURNS OFF AND THE PATIENT COULD NO LONGER FEEL IT. THE PATIENT HAD TO HAVE INS REPLACED AGAIN IN 2013 (SEE MANUFACTURER'S REPORT # 3004209178-2013-11905)BECAUSE INS WAS NOT WORKING AND WAS GIVING HER PROBLEMS OF URINATING. EVEN THOUGHT HCP REPLACED THE INS THE PATIENT WAS STILL HAVING THE SAME ISSUES. THE PATIENT WAS CURRENTLY ON PROGRAM 3, STIM WAS ON AND WAS AT 2.7V. ON PROGRAM 4 AT 2.5V THE PATIENT FELT STIM RIGHT OVER HER INS POCKET SITE AND NOT IN THE BIKE SEAT AREA. ON PROGRAM 1 AT 2.3V STIM WAS COMFORTABLE AND FELT IT IN HER BIKE SEAT AREA. THE PATIENT NOTED STIM FELT LIKE IT SHUT OFF. PATIENT SERVICES REVIEWED THE PATIENT MAY NOT ALWAYS FEEL STIM DEPENDING ON THE POSITION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336309 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention