BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3133789 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08307
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 9, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# VA022QA, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID NEU_UN KNOWN_PROG, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS RECENTLY IMPLANTED AND WAS GIVEN NO TRAINING ON THE THERAPY OR THE PROGRAMMER. THE PATIENT WAS SEEN FOR THEIR FOLLOW UP AND THEY WERE HEALING WELL. A CREAM ANTIBIOTIC WAS GIVEN FOR THE REDNESS IN THEIR URETHRA. THE PATIENT WAS SET TO PROGRAM 1 AT 0.9V AND WHEN THEY TRIED TO MAKE AN ADJUSTMENT THE PATIENT GOT A ¿ZAP.¿ IT WAS NOTED THE PATIENT COULD NOT FEEL STIMULATION ANYMORE. IT WAS STATED THE PATIENT EXPERIENCED A LOSS OF EFFECT. THE PATIENT INITIALLY HAD SOME SYMPTOM RELIEF, BUT WAS HAVING A RETURN OF SYMPTOMS AND WANTED TO INCREASE STIMULATION. IT WAS INDICATED THAT THE PATIENT WAS HAVING TERRIBLE ITCHING IN THEIR VAGINAL AREA AS WELL. THE PATIENT WAS CONCERNED THAT THE STIMULATION SENSATION WOULD MAKE THE ITCHING WORSE. A LOSS OF BLADDER CONTROL WAS ALSO REPORTED. THE BLADDER LEAKAGE WAS DESCRIBED AS A ¿GUSH OR RIVER OF URINE.¿ THIS WOULD GENERALLY OCCUR WITH NO WARNING. STIMULATION WAS INCREASED TO 1.4V AND THE PATIENT FELT IT COMFORTABLY. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER IN THREE WEEKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WAS TRYING TO WORK WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S RIGHT BUTTOCK WAS STILL VERY UNCOMFORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235596 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention