BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1253150 · Received December 5, 2008

    Report

    Report Number
    3004209178-2008-08057
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    June 1, 2008
    Report Date
    November 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN LOOKING "GREY" FOR ABOUT FIVE MONTHS. ABOUT A WEEK AGO THE PATIENT WAS HOSPITALIZED WITH EARLY STAGES OF RESPIRATORY FAILURE. THERE WAS NO REPORTED EVENT WITH A REFILL SESSION, MEDICAL PROCEDURE OR ENVIRONMENTAL EXPOSURE ASSOCIATED WITH THE CHANGE IN THE PATIENT'S COLOR OR HOSPITALIZATION AS IT WAS REPORTED TO BE A GRADUAL CHANGE. THE HOSPITAL WORK-UP DID NOT SHOW ANY REASON FOR THE RESPIRATORY FAILURE. THE PATIENT WAS PLACED ON HOME OXYGEN. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R PROGRAMMER: MODEL 8840| EXPLANTED:| CATHETER: MODEL 8709