BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3851958 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10210
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS SEEN ON (B)(6) 2014 FOR A REFILL AND HAD A DRUG CONCENTRATION CHANGE DONE WITH A BRIDGE BOLUS PROGRAMMED. THE PATIENT LEFT THE CLINIC AND WAS "FEELING FINE". LAST NIGHT, THE PATIENT DEVELOPED WITHDRAWAL; COLD, NAUSEA, VOMITING, SHAKY, AND INCREASED PAIN. THE PATIENT WENT TO THE LOCAL ER (EMERGENCY ROOM) AT 0100 AM THIS MORNING. THE MANUFACTURER REPRESENTATIVE (REP) WAS ASKED TO INTERROGATE THE PUMP, AND THE BRIDGE CALCULATIONS WERE CONFIRMED. NO ALARMS WERE SEEN IN THE LOGS. THE PUMP STATUS WAS SHOWING THE CORRECT PROGRAMMING AND A LAST CHANGE DATE OF (B)(6) 2014. THE PUMP CONTAINED MORPHINE AND BUPIVACAINE. IT WAS FURTHER REPORTED THE PATIENT HAD BEEN CURRENTLY ADMITTED TO THE HOSPITAL SINCE LAST NIGHT. THE PATIENT WAS EXPERIENCING "THROWING UP, DIARRHEA, FEVER, ON/OFF CHILL, SEIZURE LIKE EPISODES SUCH AS SHAKING AND TREMBLING, THE HEBEJEBIES". THEY WERE CURRENTLY WAITING TO CHECK THE STATUS OF THE PUMP. IT WAS FURTHER REPORTED, THE PATIENTS CURRENT STATUS WAS UNKNOWN. THE PUMP WAS PUT ON MINIMUM RATE AND WAS GIVEN "ORALS" AND SENT TO THEIR MANAGING HEALTHCARE PROFESSIONAL (HCP). IT WAS FURTHER REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS GIVEN ORAL MORPHINE AND THE PUMP WAS SET TO MINIMUM DOSING. THE PATIENT WAS OFFERED A DYE STUDY, BUT PATIENT DECLINED AND WANTED THE PUMP OUT. THE ISSUE HAD NOT RESOLVED AND THE SYMPTOMS/ISSUE WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328985 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization