BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2852333 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-10971
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 5, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8731SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS LATER NOTED THAT THE PATIENT WAS STILL HAD CONCERNS REGARDING HER DEVICE AND THAT SHE HAD THREE APPOINTMENTS SET UP IN (B)(6) 2012 AND (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE LAST REFILL IN (B)(6) SOMEWHERE AROUND THE (B)(6), THE PUMP WAS OBSERVED TO BE FLIPPED, "FLIPPED UPSIDE DOWN". THE HEALTHCARE PROVIDER (HCP) HAD TO MANUALLY FLIP IT BACK TO REFILL IT. PATIENT FELT THAT THE PUMP WAS NOT WORKING "RIGHT OR SOMETHING", HAS NEVER REALLY WORKED "RIGHT". PATIENT HAD NOT BEEN GETTING "GOOD RELEASE AT ALL" AND HAD TO GO BACK ON THE FENTANYL PAIN PATCHES. DRUG DELIVERED VIA THE DEVICE WAS MORPHINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention