BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3160484 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10106
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3889-28 LOT# V942571, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED ¿IT DOES NOT WORK VERY WELL.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS INQUIRING WHEN THE DEVICE WOULD NOT WORK. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF URINARY TRACT INFECTIONS (UTI). THE PATIENT HAD BACK SURGERY (B)(6) 2011, A CATHETER WAS INSERTED INTO HER BLADDER, WHICH WAS REMOVED (B)(6) 2011, AND SINCE THEN SHE HAD A HISTORY OF BLADDER INFECTIONS (UTI¿S). THE PATIENT HAD THESE SYMPTOMS BEFORE SHE WAS IMPLANTED. IT WAS NOTED THAT THE TRIAL HELPED HER A LITTLE BIT, BUT SHE HAD A BLADDER INFECTION AT THAT TIME ALSO. THE PATIENT WAS IMPLANTED AND IT WORKED NICELY FOR TWO WEEKS, BUT SINCE THEN IT HAD NOT, SINCE THE PATIENT HAD THE BLADDER INFECTIONS. THE PATIENT¿S BACKSIDE WAS SORE NOW AND WHEN SHE WASHED HERSELF BACK THERE, IT WAS TENDER AND THE DEVICE WAS LOCATED IN THE BUTTOCKS. THE PATIENT HAD A CYSTOSCOPY LAST JULY AND WAS TOLD SHE HAD CYSTITIS. THE PATIENT CURRENTLY DID NOT HAVE THE DEVICE ON AND WAS WORKING WITH HER DOCTOR. THE PATIENT STATED THE DEVICE DID NOT CAUSE THESE SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259723 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR