BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3123993 · Received May 22, 2013

    Report

    Report Number
    3004209178-2013-08028
    Event Type
    Injury
    Date Received
    May 22, 2013
    Report Date
    May 1, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: CATHETER: PRODUCT ID 8709, LOT# L73869, IMPLANTED: (B)(6) 2000. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT, THE IMPLANT SITE WAS ¿SWOLLEN SO BIG THAT IT WAS ALMOST READY TO BURST¿. SHE WAS ¿HURTING TERRIBLY¿. THE PATIENT WAS LEAKING SPINAL FLUID. SHE HAD TO GO IN EVERY DAY AND HAVE IT ASPIRATED. AN UNSPECIFIED TEST WAS DONE AND THEY DETERMINED THAT THEY NEEDED TO GO BACK IN. DURING THE REVISION, IT WAS DETERMINED THAT WHEN THEY IMPLANTED THE PUMP THE CATHETER HAD GOTTEN PUNCTURED; THERE WAS A HOLE IN THE CATHETER THAT WAS LEAKING SPINAL FLUID. THE CATHETER WAS REVISED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225909 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention