BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2955278 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02519
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING AN OVERDOSE. THE PATIENT HAD A DOSAGE ADJUSTMENT ON THE DAY PRIOR TO THE REPORT DATE, AND ON THAT SAME EVENING THE PATIENT STARTED SHOWING SYMPTOMS OF SHAKING, SNIFFLING, YAWNING AND "CAN'T EVEN STAND UP." THE REPORTER INDICATED THAT AT THAT DOSAGE ADJUSTMENT ON THE PRIOR DATE, THE HEALTHCARE PROVIDER (HCP) HAD INCREASED THE DOSE BY TOO MUCH. THE REPORTER STATED AS OF THE TIME OF REPORT, THE PATIENT WAS WAITING IN THE HCP'S CLINIC WAITING AREA TO SEE THE HCP, IN ORDER TO HAVE THE DOSE TURNED DOWN BECAUSE THE PATIENT WAS - OVERDOSING RIGHT NOW. THE PATIENT WAS DISSATISFIED WITH THE HCP AND INTENDING ON FINDING ANOTHER PROVIDED. THE MEDICATION IN THE PUMP WAS MORPHINE. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58236 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other