BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3232530 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11920
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO A HOSPITAL IN (B)(6) ON (B)(6) FOR ALTERED MENTAL STATUS. THE PATIENT WAS VISITING THE AREA AND LIVED OUT OF STATE. PER THE REPORTER THE HCP¿S AT THE FACILITY FELT THE PATIENT WAS RECEIVING ¿TOO MUCH OF A DOSE OF MEDS¿ AND WANTED THE PUMP DECREASED. ON (B)(6), THE PUMP WAS TURNED DOWN 25% AS THE PATIENT WAS UNAROUSABLE. THE FOLLOWING DAY, THE PATIENT WAS STILL HARD TO AROUSE BUT THEN BECAME AGITATED, COMBATIVE AND HAD DIFFICULTY BREATHING. THE PATIENT WAS INTUBATED. THE PATIENT WAS TRANSFERRED TO ICU. THE PUMP WAS USED TO DELIVER HYDROMORPHONE AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334964 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R