BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4781128 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-09343
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 30, 2015
    Report Date
    April 30, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V942569, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PINCHING AFTER MAGNETIC RESONANCE IMAGING (MRI). THE PATIENT WAS REMOVED AND FELT FINE. THE PATIENT RESPONDED NO WHEN ASKED IF SHE HAD A MEDICAL DEVICE IMPLANT. THE SCULP MRI WAS STARTED AND THE PATIENT WAS IN THE SCANNER FOR 3 MINUTES BUT THE RADIO FREQUENCY (RF) WAS NOT ACTIVATED. WHEN THE RF WAS TURNED ON FOR ABOUT 15 SECONDS, THE PATIENT COMPLAINED OF PINCHING. THE PATIENT WAS LARGE AND, THEREFORE, HER BODY WAS TOUCHING THE MRI SCANNER. SHE WAS REMOVED AND FELT FINE. NO ACCESSORY WAS PLACED ON THE PATIENT. THE PATIENT HAD AN MRI IN (B)(6) 2014 AND ALSO ANSWERED NO TO ALL THE MRI QUESTIONS ON THE QUESTIONNAIRE. THE PATIENT DID FINE WITH THE KNEE SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325796 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR