BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2052640 · Received April 7, 2011

    Report

    Report Number
    3004209178-2011-02685
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S EXPERIENCED DECREASED MENTAL STATUS. IT WAS FURTHER INDICATED THAT THE PATIENT'S "SATURATIONS DROPPED". THE LEVEL OF SEVERITY WAS CONSIDERED SEVERE. THE ISSUE RESULTED IN PROLONGED HOSPITALIZATION. THE MEDICATION ADMINISTERED WAS MORPHINE, AND IT WAS NOTED THAT EVENT WAS POSSIBLY RELATED TO THE DRUG. THE DAILY DOSE RATE OR CONCENTRATION OF MORPHINE WAS NOT REPORTED. OXYGEN (4L) WAS ADMINISTERED VIAL NASAL CANNULA ON (B)(6) 2011. THE INFUSION RATE WAS DECREASED BY 40% ON (B)(6) 2011, AND DECREASED BY 50% ON BOTH (B)(6) 2011 AND (B)(6) 2011. THE EVENT WAS NOTED AS ON-GOING. ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG021321N| CATHETER: MODEL 8709, LOT# N276033002| IMPLANTED: