BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4250053 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21574
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 22, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM (ER) THE DAY BEFORE THE REPORT AND WAS SLEEPY. THE PATIENT WAS ADMITTED DUE TO ANEMIA AND WORSENING LETHARGY. THE HEALTH CARE PROVIDER (HCP) WANTED THE PUMP STOPPED. THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) AND WAS LETHARGIC AND ¿COULDN¿T EVEN TALK¿. IT WAS UNKNOWN IF THE PUMP HAD BEEN REFILLED OR REPROGRAMMED RECENTLY. THE PUMP SYSTEM WAS BEING USED TO INFUSE FENTANYL. NO INTERVENTIONS OR OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736171 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| L