BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3944565 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13243
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J11004R16, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER; PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER (SN: (B)(4)) REVEALED THE CATHETER BODY WAS BROKEN. THE MOST DISTAL END OF SEGMENT 1 HAD A SLIGHT JAGGED APPEARANCE. THE MOST PROXIMAL END OF SEGMENT 2 HAD A JAGGED APPEARANCE WITH AN OVAL SHAPE WHEN VIEWED IN CROSS SECTION. THIS INDICATED THE CATHETER MAY HAVE BEEN COMPRESSED AT THIS AREA AND MOST LIKELY BROKE AT THIS POINT. THE DISTAL END OF SEGMENT 1 WAS SEEN TO HAVE MATCHED UP WITH THE PROXIMAL END OF SEGMENT 2 BASED ON MARKINGS. ANALYSIS OF THE CATHETER (SN: (B)(4)) REVEALED THE PUMP CONNECTOR HAD USER DAMAGE BEYOND INTENDED RELIABILITY. IT APPEARED AS IF SOME MELTING TOOK PLACE, BUT ANALYSIS OF THIS SEGMENT COULD NOT CONFIRM WHAT MAY HAVE CAUSED THE DAMAGE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PUMP REMOVAL/CATHETER REVISION OCCURRED TODAY. THE CATHETER WAS REMOVED AND NOTED TO HAVE NO MARKINGS. THE MANUFACTURER REPRESENTATIVE WAS QUESTIONING IF THERE DISTAL PORTION OF THE CATHETER WAS MISSING. IT WAS NOTED THE PUMP WAS USED TO DELIVER HYDROMORPHONE. IT WAS FURTHER REPORTED THE PUMP AND CATHETER WERE REMOVED FOR AN INFECTION. THE CATHETER WAS ALSO REMOVED FOR "BREAK, TEAR, HOLE". THE HCP WAS CONCERNED ABOUT THE CATHETER LEFT IN THE INTRATHECAL SPACE. THEY WERE UNABLE TO DETECT THE CATHETER ON X-RAY INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423208 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Other| R