BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX CARDIAC STENT IMPLANT

    MDR report key: 3851287 · Received May 30, 2014

    Report

    Report Number
    MW5036444
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    March 22, 2012
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT HAD FOUR MEDTRONIC RESOLUTE INTEGRITY RX CARDIAC STENT IMPLANTS IN (B)(6) OF 2012. IT HAD A POSITIVE PATCH TEST TO COBALT. COBALT IS ONE OF THE MATERIALS IN THESE STENTS. MY ALLERGIST DIAGNOSED AN ALLERGY TO MY CARDIAC STENTS. MY SYMPTOMS INCLUDE; MUSCLE AND JOINT PAIN, HEADACHE, DIZZINESS, BALANCE PROBLEMS, HEAT AND COLD INTOLERANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319290 RESOLUTE INTEGRITY RX CARDIAC STENT IMPLANT RESOLUTE INTEGRITY RX CARDIAC STENT IMPLANT MAF MEDTRONIC
    319291 RESOLUTE INTEGRITY RX CARDIAC STENT IMPLANT RESOLUTE INTEGRITY RX CARDIAC STENT IMPLANT MAF MEDTRONIC
    319292 RESOLUTE INTEGRITY RX CARDIAC STENT IMPLANT RESOLUTE INTEGRITY RX CARDIAC STENT IMPLANT MAF MEDTRONIC
    319334 RESOLUTE INTEGRITY RX CARDIAC STENT IMPLANT RESOLUTE INTEGRITY RX CARDIAC STENT IMPLANT MAF MEDTRONIC 0005997188

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Disability