BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5174739 · Received October 24, 2015

    Report

    Report Number
    3004209178-2015-21397
    Event Type
    Injury
    Date Received
    October 24, 2015
    Report Date
    September 28, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V850492, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT STEPS TAKEN TO RESOLVE THE LOSS OF STIMULATION AND LEAKING INCLUDED MAKING AN APPOINTMENT WITH THE DOCTOR. THE URINARY TRACT INFECTION HAD SO FAR BEEN RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT REPORTS AN INFECTION. SHE HAD NEUROSTIMULATOR IMPLANTED FOR FECAL BUT IT ALSO HELPS WITH URINARY. PATIENT ALSO REPORTS SHE INCREASED STIMULATION ALL THE WAY UP TO 6 AND SHE WAS NOT FEELING ANY TAPPING/STIMULATION SENSATION. THE PATIENT REPORTS IF SHE HAD TO GO TO THE BATHROOM AND CAN'T GET TO THE TOILET. SHE WILL LEAK BAD, BUT IT'S NOT LIKE SHE WAS LEAKING ALL THE TIME. SHE WAS NOT HAVING A PROBLEM WITH HER STOOLS, BUT THEN STATES ONCE IN A WHILE SHE DOES BUT SHE CAN RELATED IT TO SOMETHING SHE ATE. LAST NIGHT SHE "HAD IT HAPPEN REALLY BAD" BUT SHE WAS ON A PILL CALLED "BACRUM" BECAUSE SHE HAS A URINARY TRACT INFECTION. THE PATIENT WAS SURE THAT WAS WHAT WAS GIVING HER DIARRHEA. SHE HAD TO GO TO AN URGENT CARE AND THEY TOOK A CULTURE OF HER URINE BECAUSE IT LOOKED LIKE MERLOT WINE, AND THEY HAD GIVEN HER "SULFA" ON (B)(6) 2015. THE HCP (HEALTHCARE PROVIDER) CALLED HER TO LET HER KNOW THAT HER BACTERIAL INFECTION WAS RESISTANT TO THAT DRUG. THEY PRESCRIBED THE "BACRUM" WHICH THE PATIENT STATES WAS ONE OF THE WORST ANTIBIOTIC, THERE WERE ALWAYS NAUSEOUS, DON'T FEEL LIKE EATING, HAVE COTTON MOUTH, AND DIARRHEA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702636 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention