BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2831975 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10253
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 16, 2012
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V846377, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ZERO BOWEL CONTROL AND THAT THE IMPLANT HAD NOT WORKED AT ALL. IT WAS NOTED THAT THE PATIENT HAD GONE THROUGH CHEMOTHERAPY AND RADIATION THERAPY, WHICH AFFECTED HER URINARY CONTROL AND WAS DOING BETTER, BUT WHEN THE IMPLANT WAS ON IT WAS STATED SHE LEAKED URINE. THE REPORTER STATED THAT SHE HAD NOT EVEN 1 % RELIEF FROM HER BOWEL ISSUE. THE REPORTER FURTHER STATED IF THE DEVICE WOULD ACCIDENTALLY TURN OFF, SHE WOULD HAVE "MAJOR ACCIDENTS." IT WAS ALSO STATED THAT SHE HAD "SOME IMPROVEMENT WITH THE URINARY, BUT LITTLE TO NO IMPROVEMENT WITH THE DEVICE FOR FECAL." IT WAS UNCLEAR WHAT WAS MEANT BY THIS STATEMENT, FOR RECORDS SHOWED THE PATIENT HAD ONE DEVICE FOR URINARY INCONTINENCE. THE REPORTER ALSO STATED THAT SHE HAD "TERRIBLE PAIN" BACK AT THE BEGINNING OF (B)(6) 2012. IT WAS STATED THAT AN X-RAY WAS PERFORMED AND IT WAS CONFIRMED THERE WAS NO INFECTION. THE REPORTER ALSO STATED THAT SHE HAD THIS PAIN ABOUT 20 TIMES PER, DESCRIBED THE PAIN AS "INTERMITTENTLY LIKE A BURNING PAIN, VERY INTENSE." THE PAIN WAS FURTHER DESCRIBED AS "BURNING BAD PAIN THAT WAS SO BAD IT MADE HER EYES ROLL TO THE BACK OF HER HEAD." IT WAS NOTED THAT THERE WAS NO POCKET FLUID AND THE PATIENTS" HEALTH CARE PROVIDER STATED, "THE ONLY THING TO DO WAS TO TAKE IT OUT." IT WAS STATED THE PATIENT PUT ESSENTIAL OILS ON HER HIP FOR THE PAIN AND AFTER 6 WEEKS THE PAIN STOPPED. THE REPORTER ALSO STATED THAT THE CURRENT STIMULATION SETTING WOULD BOTHER HER LEFT VAGINAL AREA AND WHEN SHE MOVED, THE DEVICE WOULD "SHOCK HER A BIT." ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WOULD BE INCLUDED IN A SUPPLEMENTARY REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1