BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2984331 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03191
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN IMPLANT PROCEDURE, THE PATIENT'S PHYSICIAN EXPERIENCED DIFFICULTY CONNECTING THE PROXIMAL SEGMENT OF THE CATHETER TO THE DISTAL SEGMENT. WHEN TRYING TO CONNECT TO THE COLLET, HE COULD NOT ADVANCE THE CATHETER IN EITHER SIDE AND IT WAS NOTED THAT "HE COULD NOT ADVANCE THE CATHETER PAST THE COLLET". IT WAS FURTHER NOTED THAT "THE CATHETER JUST KIND OF FELL BACK OUT AND IT WAS NOT ADVANCING". IT WAS LATER DETERMINED THAT THE CATHETER WOULD NOT ADVANCE BECAUSE THE CATHETER HAD BEEN TRIMMED AT AN ANGLE AND A PIECE OF CATHETER "WAS GETTING STUCK". THE PHYSICIAN RE-TRIMMED THE CATHETER AT A FLUSH ANGLE AND IT FIT PROPERLY INTO THE COLLET. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS, AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. THE MEDICATION USED WITHIN THE SYSTEM WAS HYDROMORPHONE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87035 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR