BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4931756 · Received July 22, 2015

    Report

    Report Number
    3004209178-2015-13838
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    June 29, 2015
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3093-28, LOT# V508978, IMPLANTED: (B)(6) 2010, 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 COULD NOT FEEL STIMULATION ON PROGRAMS 1 OR 2. WHEN SHE INCREASED STIMULATION ON PROGRAM 3 AND 4 THE STIMULATION DID NOT GO UP ACCORDINGLY, BUT SHE WOULD GET STIMULATION THAT WAS UNCOMFORTABLE ALL OF A SUDDEN THAT CAUSED HER INTERMITTENT PAIN. SHE ALSO HAD A SUDDEN RETURN OF SYMPTOMS. SHE NOTICED SOMETHING WAS OFF ABOUT A WEEK AGO AND HAD SERIOUS CRAMPING ON THE PREVIOUS SATURDAY. THE PATIENT'S THERAPY WAS ON AT THE TIME OF THE REPORT AND THE SITUATION WAS NOT RESOLVED. SHE INTENDED TO SEEK HER DOCTOR'S SERVICE TO ADDRESS THE THERAPY ISSUE. NO INTERVENTIONS OR PATIENT OUTCOME WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477650 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1