BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202151 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00650
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    April 9, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8709, LOT# J0039937R, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT FELT BOTH UNDER AND OVERDOSE SYMPTOMS SINCE THE TIME OF IMPLANT. THE PATIENT DID NOT DO ANY HEAVY ACTIVITIES OTHER THAN HOUSEWORK. A DYE STUDY WAS PERFORMED. NO ISSUE APPEARED IN THE EVENT LOGS. THERE WERE NO DISCREPANCIES AT REFILLS. IT WAS NOTED THAT THE HEALTH CARE PROFESSIONAL PLANNED TO STOP THE PUMP OR PUT AT MINIMUM RATE MODE AND MANAGE THE PATIENT ORALLY. THE HEALTH CARE PROFESSIONAL INQUIRED INFORMATION ABOUT WEANING THE PATIENT OFF THE MEDICATIONS. THE PUMP WAS USED TO DELIVER MORPHINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301028 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention