BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3103217 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07430
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 19, 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
    PR, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28 LOT# V940067, IMPLANTED: 2012 (B)(6) PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT "BURNING" IN THE "GLUTINA" BUTTOCKS AREA DURING MAGNETIC RESONANCE IMAGING (MRI). THE HEALTH CARE PROVIDER (HCP) WAS UNAWARE THE PATIENT HAD AN IMPLANT WHEN SHE ARRIVED THE SATURDAY PRIOR TO THE REPORT TO HAVE THE MRI. WHEN THE SCAN STARTED THE PATIENT FELT A "BURNING SENSATION" IN HER BUTTOCKS AREA. THE SCAN WAS STOPPED AND THE PATIENT WAS DOING FINE BECAUSE SHE CAME BACK IN THE DAY OF THE REPORT TO CONTINUE THE MRI. THE HCP REFUSED TO SCAN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203636 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1