BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3072235 · Received April 23, 2013

    Report

    Report Number
    9612164-2013-00456
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 22, 2012
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE-ALLERGIC REACTION. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE-ALLERGIC REACTION. UNABLE TO CONFIRM COMPLAINT. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: PATIENT HAS BEEN CONFIRMED AS BEEN ALLERGIC TO COBALT. CONCLUSION: PATIENT HAS BEEN CONFIRMED AS BEEN ALLERGIC TO COBALT. FDA REFERENCE # MW5036444.

    Description of Event or Problem · 1

    THE PATIENT HAD FOUR RESOLUTE INTEGRITY DRUG ELUTING STENTS IMPLANTED WITHOUT ANY ISSUE REPORTED. HOWEVER, IT WAS REPORTED THAT POST IMPLANT THE PATIENT PRESENTED WITH SYMPTOMS OF ALLERGIC REACTION INCLUDING DIZZINESS, RINGING IN EARS, BALANCE ISSUES, NAUSEA, TINGLING IN TOES AND PALMS, JOINT PAINS, CHILLS AND BLOOD PRESSURE FLUCTUATION. IT WAS REPORTED THAT PATIENT ARTERIES ARE CLEAR AND THERE IS NO SCAR TISSUE OBSERVED. IT WAS REPORTED THAT PATIENT HAS BEEN SEEN BY SEVERAL SPECIALISTS; HOWEVER SYMPTOMS PERSIST.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMS THAT THE PATIENT HAS HAD A POSITIVE PATCH TEST TO COBALT. THE MEDTRONIC RESOLUTE INTEGRITY STENT IS MADE FROM A COBALT ALLOY. THE PATIENTS SYMPTOMS INCLUDE; MUSCLE PAIN, HEADACHE AND HEAT AND COLD INTOLERANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175625 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006013055

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention ASPIRIN