BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3072796 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06740
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 27, 2013
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD BEEN GETTING DECREASED EFFICACY. A DYE STUDY WAS PERFORMED AND THE HEALTHCARE PROFESSIONAL WAS UNABLE TO ASPIRATE THE CATHETER. IT WAS FOUND THAT THE CATHETER HAD BEEN "DOING A 180" AND THE TIP WAS POINTING DOWN. THERE WAS A KINK NOTED IN THE CATHETER AS WELL. THE CATHETER WAS REPLACED AND THE PATIENT'S DOSE WAS DECREASED. THE DEVICE SYSTEM WAS INFUSING INFUMORPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174875 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention