BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3240817 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12092
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 25, 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
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8596SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8596SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEEDED TO HAVE A CAT SCAN DUE TO AN ¿UNVERIFIED¿ GRANULOMA OR CATHETER KINK. THE PRIOR WEEK, THE PATIENT HAD TO CALL 911 BECAUSE, HE FELT LIKE ¿ALL OF A SUDDEN WAS GETTING TOO MUCH MEDICINE¿; LIKE HE HAD BEEN RUN OVER WITH WAY TOO MUCH MEDICINE, THE EXACT SAME SENSATIONS AND THEN IT WENT AWAY AND HAS NOT HAPPENED SINCE. IT WAS NOTED THAT WHEN THE CURRENT PUMP WAS IMPLANTED THE CATHETER WAS NEVER CHANGED OUT. IT WAS ALSO NOTED THAT AT THE TIME OF IMPLANT ¿THEY HAD TO CLEAN OUT A LOT OF SCAR TISSUE IN THE POCKET¿. PER THE REPORTER, THE PATIENT DOES 'GROW SCAR TISSUE'. SINCE THE IMPLANT THE PATIENT WASN¿T GETTING THE MEDICATION CONSISTENTLY, LIKE IT HAD A KINK IN IT. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340660 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Other