BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3973465 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13827
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 8, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT# VA0886N, IMPLANTED: (B)(6) 2013, 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 PATIENT HAD STIMULATION FOR 6 MONTHS AND ABOUT 2 WEEKS NOW PRIOR TO CALL PATIENT WAS NOTICING A DIFFERENT IN THE AREA WHERE SHE WAS FEELING STIMULATION (IMPULSES). THE PATIENT STATED THAT SHE KNOWS THAT SOMETIMES IT FELT DIFFERENTLY WHEN BENDING OVER OR POSTURING DIFFERENT, ¿SOMETIMES SHE WAS FEELING IT LESS OR MORE, BUT NOW WAS FEELING IT ON TOP OF WHERE PATIENT WAS FELT IT, IN A DIFFERENT AREA AT THE SAME TIME." IT WAS INDICATED THAT THE NIGHT OF THE CALL PATIENT TRIED HER OTHER SETTINGS AND THEY WERE COMPLETELY IN THE WRONG AREA. ADDITIONAL INFORMATION RECEIVED A DAY LATER INDICATED THAT PATIENT FELT STIMULATION IN HER UPPER BUTTOCK WHEREAS BEFORE SHE FELT IT IN THE GROIN AREA. IT WAS INDICATED THAT PATIENT COULD ONLY BE SEEN BY HEALTH CARE PROVIDER NOT UNTIL (B)(6). IT WAS LATER REPORTED THAT PATIENT LOSS OF THERAPEUTIC EFFECT AND THAT SHE WAS ¿FRUSTRATED¿ BECAUSE SHE HAD THE SURGERY 8 MONTHS AGO AND HAD A DIFFERENCE IN THE SENSATION SINCE (B)(6)2014 AND WANTED KNOW WHY THERE WAS A DIFFERENCE SENSATION. IT WAS INDICATED SHE COULD NOT GET TO SEE THE HEALTHCARE PROVIDER FOR 3 MONTHS AND COULD NOT WAIT THAT LONG. IT WAS REPORTED THAT THEIR THERAPY WAS NOT WORKING AS EXPECTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN IN THE OFFICE AND THEIR IMPEDANCES WERE NORMAL. IT WAS NOTED THAT THE PATIENT HAD A URINARY TRACT INFECTION (UTI) PREVIOUSLY AND WAS DOING FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450664 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention