BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3172709 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10437
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 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: 8637, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: PUMP. PRODUCT ID: 8703, LOT# J94142123, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE SYSTEM WAS USED TO INFUSE LIORISAL. THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THAT THE REPORTER HAD NO INFORMATION ON THE ISSUE. ¿PATIENT IS FINE.¿ IT WAS NOTED THAT THERE WERE NO SIGNS OR SYMPTOMS ASSOCIATED WITH THE REPORTED EVENT. THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT AND THERE WAS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A PATIENT¿S PUMP REPLACEMENT, THEY COULD NOT ¿CLEAR THE CATHETER¿. DURING THE REPORT, THE REPRESENTATIVE ALSO EXPERIENCED INTERMITTENT TELEMETRY ISSUES STATING ¿WHEN THE HEALTHCARE PROFESSIONAL PICKED IT UP, IT STOPPED THE TELEMETRY¿. THIS RESOLVED AFTER NORMAL TROUBLESHOOTING, AND TELEMETRY WAS COMPLETED. IT WAS LATER REPORTED THAT THE NEW PUMP WAS PRIMED ON THE BACK TABLE AND CONNECTED TO THE CATHETER. THE PATIENT WAS DOING FINE. THE PATIENT¿S OLD PUMP WAS REPLACED DUE TO NORMAL END OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274394 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR