BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3162768 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10152
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE CATHETER. (B)(4). A PORTION OF THE CATHETER WAS RETURNED. ANALYSIS OF THE RETURNED PORTION REVEALED THAT THE MOST DISTAL END OF THE CATHETER SEGMENT HAD A SLIGHT JAGGED LOOK TO IT ALONG WITH A SLIGHTLY OVAL SHAPE WHEN VIEWED IN CROSS SECTION. THIS INDICATED THE CATHETER WAS COMPRESSED AT THIS AREA AND MOST LIKELY BROKE AT THIS POINT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED A POCKET REVISION WAS SCHEDULED. THE PATIENT RECENTLY HAD A CATHETER REVISION AND AN 8780 CATHETER WAS PLACED. PER THE REPORTER AT THE END OF THE INCISION AT THE PUMP POCKET WAS A SMALL HOLE AND THE PUMP COULD BE SEEN THROUGH THE INCISION. THE PATIENT REPORTED THE INCISION NEVER HEALED RIGHT SINCE THE CATHETER REVISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THERE WERE NO PATIENT SYMPTOMS AND NO CAUSE WAS DETERMINED AS TO WHY THE INCISION FROM THE CATHETER REVISION WOULD NOT HEAL. IT WAS INDICATED THE PUMP REVISION SURGERY HAD BEEN PERFORMED/SCHEDULED. THE PATIENT WAS NOTED TO BE ¿FINE¿ AND RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT EXPERIENCED PAIN. A BREAK IN THE CATHETER WAS LOCATED AT THE ANCHOR SITE AND THE CATHETER WAS SUCCESSFULLY REVISED. THE PATIENT WAS REPORTED AS ALIVE WITHOUT INJURY OR ADVERSE EVENT. THIS DEVICE SYSTEM DELIVERED INFUMORPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262703 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention