BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3163221 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-04692
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 16, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. PATIENT REPORTED THEIR FIRST DEVICE DID NOT WORK. ACCORDING TO THE PATIENT SHE HAD ONE IN FOR THREE YEARS BUT, THE FIRST ONE DID NOT WORK; IT DID NOT WORK AT ALL. SYSTEM USED TO DELIVER BUPIVACAINE, MORPHINE. A FOLLOW UP HAVE BEEN REQUESTED BUT NO ADDITIONAL INFORMATION HAD BEEN PROVIDE AS OF THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT ON (B)(6) 2009 THE PATIENT¿S FIRST IMPLANTED PUMP ¿DIDN¿T WORK¿ AND ¿NEVER WORK FOR THE WHOLE TWO YEARS¿. IT WAS REPORTED THAT THE PATIENT WAS INSTRUCTED NOT TO TAKE ORAL MEDICATION AFTER THE FIRST PUMP PLACEMENT. IT WAS NOTED THAT PATIENT'S ORAL MEDICATION USAGE INCREASED AFTER TRAVELING. IT WAS NOTED THAT THE HEALTHCARE PROVIDER (HCP) AND PATIENT DISCUSSED PAIN MEDICINE FOR ONE YEAR AND THE PATIENT SWITCHED HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264158 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention