BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3170513 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10396
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS EMPTY FOR ONE YEAR. IT WAS NOTED THAT THE PATIENT WAS NOT COMPLIANT WITH THE THERAPY. THE PATIENT WAS TAKING ORAL MEDICATION WITH THE PUMP THERAPY, WHICH CAUSED THE PATIENT TO PASS OUT AND THE PATIENT WENT INTO A COMA. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER WOULD NOT SEE THE PATIENT DUE TO PATIENT COMPLIANCE. IT WAS NOTED THAT THE PUMP WAS RECOMMENDED FOR REMOVAL DUE TO THE LENGTH OF TIME THE PUMP WAS EMPTY. IT WAS NOTED THAT THE PATIENT WAS USING ORAL MEDICATION. IT WAS NOTED THAT THE PATIENT WOULD LIKE TO HAVE THE PUMP REFILLED. THE DEVICE SYSTEM WAS USED TO DELIVER 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
    271734 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R