BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3365716 · Received September 24, 2013

    Report

    Report Number
    3004209178-2013-16863
    Event Type
    Injury
    Date Received
    September 24, 2013
    Report Date
    September 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V813487, IMPLANTED: (B)(6) 2011. 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 THE PATIENT EXPERIENCED PAIN AND SWELLING AROUND THE BATTERY SITE THE DAY AFTER ¿DOING TOO MANY THINGS¿ AND DOING SOME GARDENING. IT WAS NOTED THAT THE PATIENT MAY HAVE OVERDONE IT. IT WAS REPORTED THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY, AND NOTED IT WAS USELESS. IT WAS STATED THEIR DEVICE WAS SUDDENLY CAUSING HER A GREAT DEAL OF PAIN AND STARTED TO PROTRUDE OUT OF HER BODY. THE PATIENT WAS PUT ON AN ANTIBIOTIC TO SEE IF THE PAIN AND SWELLING SUBSIDE. IF IT DID NOT SUBSIDE THE DOCTOR RECOMMENDED REMOVAL. THE PATIENT STATED THE DEVICE NEVER HELPED THE PATIENT PROPERLY, BUT KEEPING IT IN ¿MAY HAVE HELPED.¿ ¿ANYTHING WAS BETTER THAN SEEKING THE REMOVAL AND OPERATION. SHE WOULD LIKE TO KNOW MORE ABOUT THE SUCCESS AND FAILURE OF THE IMPLEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481430 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention