BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2962561 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02683
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, PRODUCT TYPE - PROGRAMMER, PHYSICIAN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S PUMP WAS TURNED OFF DUE TO SEVERE VOMITING AND HEADACHE. THE PATIENT WAS IMPLANTED WITH THE PUMP ON (B)(6) 2013 AT 930AM, AND BY 530 PM THE PATIENT WAS VOMITING. THE PATIENT WAS IN THE EMERGENCY ROOM (ER) AT THE HOSPITAL VOMITING NONSTOP FOR 5 HOURS AND HAD A HEADACHE. A SPINAL HEADACHE WAS RULED OUT. THE ER HEALTHCARE PROVIDER (HCP) DID NOT THINK THE SYMPTOMS WERE DUE TO THE PUMP OR PUMP MEDICATIONS AT THE TIME, BUT OPTED TO TURN THE PUMP OFF UNTIL THE REGULAR HCP SAW THE PATIENT THE NEXT DAY, OR THE FOLLOWING MONDAY. IT WAS LATER REPORTED THAT AFTER TURNING THE PUMP OFF, THE PATIENT ENDED UP GOING HOME AND DIDN'T HAVE ANY ISSUES WITH IT OVER THE WEEKEND. THE REPORTER THEN INDICATED THEY FELT THE ISSUE WAS TO DO WITH A MISCALCULATION OF THE PUMP BOLUS THAT HAD BEEN DELIVERED. ON (B)(6) 2013, THE HCP WAS HAVING THE PUMP TURNED BACK ON, BUT AT THE LOWEST MINIMUM RATE. THE EVENT AND PATIENT OUTCOME WAS NOT PROVIDED. THE MEDICATION BEING DELIVERED WAS MORPHINE. 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
    65936 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN NEURO CATHETER