BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3036152 · Received April 4, 2013

    Report

    Report Number
    3004209178-2013-04645
    Event Type
    Injury
    Date Received
    April 4, 2013
    Report Date
    March 18, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# V896802, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED "SHOCKING SENSATIONS." THE PATIENT STATED, SHE UNDERWENT "ELECTRICAL TESTING" WHERE SHE HAD NEEDLES INSERTED "INTO THE MUSCLE IN THE BODY." SHE FURTHER STATED, THESE TESTS INVOLVED "SHOCKING TO TEST THE NERVES" AND WERE PERFORMED "ALL OVER HER BODY." THE PATIENT REPORTED SINCE THESE TESTS SHE EXPERIENCED "SHOCKING SENSATIONS FROM HER DEVICE." IT WAS NOTED THAT THE DEVICE WAS "TURNED OFF DURING THE TWO TESTS" AND THAT SHE "FAILED THE TESTS IN THE VAGINAL AND RECTAL AREA." THE PATIENT STATED THAT "WHENEVER SHE TURNS THE DEVICE OFF OR WHEN SHE HAS DIARRHEA, THAT SHE HAS TOO MUCH STIMULATION AND CAUSES BLEEDING." IT WAS NOTED, THE PATIENT WOULD "TURN THE DEVICE OFF TO GIVE HER BOWELS A CHANCE TO RELAX." THE PATIENT FURTHER NOTED THAT "SHE NEEDED THE DEVICE ON TO HAVE A BOWL MOVEMENT." THE PATIENT STATED, SHE "HAD NO BOWL PROBLEMS BEFORE SHE WAS IMPLANTED" WITH THE DEVICE. IT WAS REPORTED, THE PATIENT WAS HAVING HER DEVICE EXPLANTED SO SHE COULD HAVE AN MRI. IT WAS NOTED, THE MRI WAS BEING PERFORMED DUE TO "A SPINAL PROBLEM" AND "ONGOING BACK AND NECK PAIN ISSUES." THE PATIENT WAS REDIRECTED TO HER HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENTS DEVICE WAS REMOVED. IT WAS FURTHER NOTED THAT THE PATIENT WAS GOING TO HAVE A NEW DEVICE IMPLANTED FOLLOWING THE MRI. IT WAS NOTED THAT THE PATIENT HAD A CATHETER. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138873 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention