BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202430 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04740
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    March 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE ERRORS ON THE PRESCRIPTION WHILE REFILLING A PATIENT. THE PRESCRIPTION WAS SENT BACK TO THE PHARMACY TO GET CLARIFICATION BEFORE THE HEALTHCARE PROVIDER (HCP) WAS WILLING TO ATTEMPT TO REFILL THE PATIENT. THE PATIENT HAD DILAUDID 2 MG/ML IN HIS PUMP AT .1 MG/DAY AND THE HCP DECIDED TO ADD BUPIVACAINE TO THE PUMP AT 2.5 MG/ML AND DILAUDID 1MG/ML AT .1 MG/DAY OF DILAUDID. NO PROBLEM WITH THE PUMP, THERAPY, OR PROGRAMMING WAS REPORTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD SURGERY (B)(6) 2012. THERE WERE NO ADDITIONAL DETAILS REPORTED REGARDING THE SURGERY. IT REMAINS UNKNOWN IF IT WAS RELATED TO DEVICE OR THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302498 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention