BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203129 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04826
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    November 1, 2006
    Report Date
    September 17, 2012
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER FIRST PUMP (IMPLANTED IN 2006) REMOVED BECAUSE IT "DID NOT WORK." IT WAS STATED THAT SHE GOT A NEW CATHETER AND PUMP THE WEEK AFTER IMPLANT. IT WAS ALSO STATED THAT THE "PUMP NEVER WORKED FOR HER BECAUSE IT NEVER TOOK HER PAIN AWAY." PLEASE REFER TO MFG. REPORT # 3004209178-2013-04769 REGARDING THE LACK OF THERAPEUTIC EFFECT. IT WAS LATER REPORTED BY THE PATIENT'S HEALTHCARE PROVIDER (HCP) THAT THERE WAS NO RECORD OF THE PUMP OR CATHETER BEING REVISED OR REMOVED. IT WAS UNCLEAR IF THE PUMP AND CATHETER WERE ACTUALLY REPLACED A WEEK AFTER IMPLANT. THE PUMP WAS USED TO INFUSE MORPHINE OF UNKNOWN CONCENTRATION AND DOSAGE (CONCENTRATION INCREASES WERE NOTED MAY 2007 10MG/ML; JULY 2007 20MG/ML, 13.2 MG/DAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302709 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention