BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2955065 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02501
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 15, 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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT PROGRAMMER: MODEL 8835, SERIAL# (B)(4). CATHETER: MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. CATHETER: MODEL 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    A CATHETER REVISION OCCURRED. IT WAS NOTED THAT THE PATIENT EXPERIENCED PAIN AT THE CATHETER TRACT. AN X-RAY REVEALED CATHETER DISLODGEMENT AND IT WAS RESIDING IN THE ANCHOR POCKET. NEW DISTAL SEGMENT WAS IMPLANTED AND CONNECTED TO THE REMAINING CATHETER. PATIENT STATUS NOTED AS "FINE AND NOT INJURED." THE DEVICE SYSTEM WAS USED TO INFUSE SUFENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58344 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention