BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3247941 · Received July 25, 2013

    Report

    Report Number
    3004209178-2013-12321
    Event Type
    Injury
    Date Received
    July 25, 2013
    Report Date
    July 1, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V881399, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# NJD060606N, PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL IN THE SHOWER THREE DAYS AGO AND IT HURT ¿LIKE HECK.¿ THE PATIENT FELL RIGHT ON THE DEVICE AND MAY HAVE HURT HER RIB ALSO. IT WAS NOTED THAT THE PATIENT THOUGHT SHE MIGHT HAVE A BLADDER INFECTION. THE PATIENT HAD BEEN GOING TO THE BATHROOM ALL THE TIME EVER SINCE THE FALL AND ACTUALLY WET THE BED, WHICH THE PATIENT DOES NOT DO. THE PATIENT WAS CURRENTLY AT 5.8 V WITH THE DEVICE ON, AND WAS ABLE TO INCREASE STIMULATION. THE PATIENT WAS DIRECTED TO CONTACT HER PHYSICIAN.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THAT PRIOR TO BEING ABLE TO INCREASE STIMULATION, THE PATIENT WAS INITIALLY UNABLE TO ADJUST STIMULATION. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD CONCERNS WITH WHERE THEIR DEVICE WAS. AFTER THE FALL, IT SEEMED THE DEVICE PRESSED INTO THEIR BACK AND HURT. IT WAS STATED TO ¿SEEM ALL RIGHT¿ AFTER A PERIOD OF TIME. IT WAS INDICATED THE PATIENT SEEMED TO HAVE BLADDER INFECTIONS SINCE THE FALL. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349489 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention