BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3081285 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06974
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 9, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# VA0715N, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S FIRST PROGRAM DIDN'T HELP AND TWO SUBSEQUENT ONES DIDN'T HELP EITHER. THE PATIENT REPORTEDLY SOAKED ONE PAD ON ONE OF THE PROGRAMS WHILE SHE WAS WALKING AND URINATED A BIT ON ANOTHER PAD WHILE ON A DIFFERENT PROGRAM. THE REPORTER INDICATED THAT THE PATIENT FELT "TINGLING" DOWN HER RIGHT LEG AND TOES, WHICH "MADE HER TOES CURL" WHEN SHE LAY DOWN. THE PATIENT TRIED ANOTHER PROGRAM, BUT THAT "SEEMED TO STIMULATE IN HER LEFT CHEEK." THIS PARTICULAR PROGRAM HOWEVER HELPED THE PATIENT THE MOST WITH SYMPTOMS. IT WAS NOTED THAT THE PATIENT WAS DISAPPOINTED WITH RESULTS. FOLLOW-UP WITH THE PATIENT'S HEALTHCARE PROVIDER (HCP) INDICATED THAT THE CAUSE OF THE EVENT WAS THAT THE PATIENT INCREASED THE "INTENSITY" OF THE DEVICE. THE PATIENT'S PROGRAM WAS CHANGED AND INTENSITY DECREASED. IT WAS LATER REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2013 FOR THE "SHOCK" FEELING DURING WHICH TIME SETTINGS WERE ADJUSTED BY THE PATIENT'S HCP. THE PATIENT WAS SUBSEQUENTLY SEEN ON (B)(6) 2013 TO ADDRESS CONCERNS OF ALLERGY TO NICKEL. THIS METAL CONCERN WAS NOT RESOLVED AS THE PATIENT WAS INFORMED THAT "IT WAS SIMPLY HEALING." IT WAS NOTED THAT THE PATIENT WAS GOING TO FOLLOW-UP IF SHE STILL HAD ISSUES.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LOCATION (DOWN HER RIGHT LEG AND TOES) WAS NOT WHERE THE PATIENT WAS "SUPPOSED TO" FEEL THE STIMULATION, SO THEY TURNED IT DOWN. IT WAS NOTED THAT THE PATIENT WAS DISAPPOINTED WITH RESULTS BECAUSE SHE URINATED "TOO MUCH". IT WAS REPORTED THAT THE PATIENT "PEED" HALFWAY ON A WALK BUT IT WASN'T A "GUSHER". (B)(6) 2013 LFC (HCP): FOLLOW-UP WITH THE PATIENT'S HEALTHCARE PROVIDER (HCP) INDICATED THAT THE CAUSE OF THE EVENT WAS THAT THE PATIENT INCREASED THE "INTENSITY" OF THE DEVICE. THE PATIENT'S PROGRAM WAS CHANGED AND INTENSITY DECREASED. (B)(6) 2013 PATLTR (CON): IT WAS LATER REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2013 FOR THE "SHOCK" FEELING DURING WHICH TIME SETTINGS WERE ADJUSTED BY THE PATIENT'S HCP. THE PATIENT WAS SUBSEQUENTLY SEEN ON (B)(6) 2013 TO ADDRESS CONCERNS OF ALLERGY TO NICKEL. THIS METAL CONCERN WAS NOT RESOLVED AS THE PATIENT WAS INFORMED THAT "IT WAS SIMPLY HEALING" IT WAS NOTED THAT THE PATIENT WAS GOING TO FOLLOW-UP IN THE SUMMER IF SHE STILL HAD ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180880 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1