BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3981079 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13965
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 10, 2014
    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 MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA08CX7, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE STIMULATION WAS TURNED ON, THE PATIENT STATES SHE HAD AN MRI OF HER BACK A WHILE AGO (1.5 YEARS AGO). THE PATIENT WAS NOT SURE HER THERAPY WAS ON AND SHE FELT "TINGLING IN HER ABDOMEN" JUST BELOW HER BELLY BUTTON. THE PATIENT STATES IT FELT LIKE A TENS UNIT. MRI TECHNICIAN TOLD THE PATIENT "YOU'LL BE FINE". THE PATIENT STATES THAT SHE DID FOLLOW UP WITH HER HEALTHCARE PROVIDER ABOUT THE EXPERIENCE. THE PATIENT STATES THAT IT SEEMED AT THE TIME THAT THE MRI TECHNICIAN JUST DID NOT CARE THAT SHE HAD AN IMPLANT DEVICE. THE PATIENT STATES SHE WAS GOING TO HAVE AN MRI. THE PATIENT STATES OF THE NECK INITIALLY. THE PATIENT STATES THAT THE MRI WAS OVER HEAD AND THEN PATIENT STATES AGAIN MRI WAS OF THE NECK. THE PATIENT STATES THREE MONTHS AGO, THE PATIENT HAD HER FIRST MRI OF HER NECK. THE PATIENT DID NOT FEEL INTERACTION. THE PATIENT STATES SHE TURNED HER THERAPY OFF AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456304 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR