BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4802410 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-09838
    Event Type
    Injury
    Date Received
    May 28, 2015
    Report Date
    May 6, 2015
    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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8598A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DYE STUDY WAS PERFORMED ON THE DAY OF REPORT BECAUSE THE PATIENT HAD A CHANGE IN THERAPY EFFECT. IT WAS NOT KNOWN WHEN THE INADEQUATE THERAPY RELIEF BEGAN. IT WAS DETERMINED THAT THE CATHETER WAS KINKED OR SPLIT. THE CATHETER WAS SCHEDULED TO BE REVISED ON (B)(6) 2015. IT WAS LATER REPORTED THAT THE CONFIRMATION OF THE CATHETER KINK OR SPLIT WAS UNABLE TO BE DETERMINED BECAUSE IT COULD NOT BE CLEARLY DETECTED. THE HEALTHCARE PROVIDER WAS UNABLE TO ASPIRATE, THE DYE STUDY WAS NOT POSSIBLE. THE PUMP WAS USED TO INFUSE COMPOUNDED BACLOFEN AND MORPHINE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347184 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention