BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3900234 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12198
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 9, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), PRODUCT TYPE CATHETER. PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), PRODUCT TYPE CATHETER. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WENT LAST WEEK FOR A REFILL AND THEY DID A CONTRAST IMAGING ON IT AND THE PUMP WAS LEAKING AND ONE OF THE TUBES HAS A BLOCKAGE, (THE CATHETER). THE HCP SENT THE PATIENT HOME AND THE PATIENT HAD A TENTATIVE DATE OF (B)(6) 2014. PER THE REPORTER THE PUMP IS ¿KIND OF OVERDOSING THE PATIENT CONSTANTLY¿. THE REPORTER STATED THAT THEY HAD SPOKEN TO THE HCP AND THEY HAD ¿DROPPED THE BALL¿. THE REPORTER STATED THE PUMP HAD MORPHINE AND CLONIPINE OR CLONIDINE AND SOMETHING ELSE BUT DOESN¿T REMEMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377920 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Other