BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2905122 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00390
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FENTANYL OVERDOSE IN (B)(6) 2012. THE REPORTER STATED THAT THE PATIENT'S PRIMARY PHYSICIAN WAS OVERDOSING THE PATIENT ON FENTANYL WHERE HIS HAIR WAS COMING OUT AND HE WAS BREAKING OUT IN SORES ALL OVER HIS BODY. ANOTHER HEALTHCARE PROVIDER (HCP) STATED THAT "THIS WAS A PLAIN CASE OF FENTANYL OVERDOSE". AFTER REQUEST, THE PATIENT WAS CHANGED TO DILAUDID, BUT HE STILL NOTED DISSATISFACTION WITH HIS PRIMARY PHYSICIAN. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12917 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other