BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2431777 · Received January 30, 2012

    Report

    Report Number
    3004209178-2012-00617
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 9, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: (PROXIMAL CATHETER REV SEG) MODEL: 8578, SERIAL #: (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: UNK. CATHETER: MODEL: 8709, SERIAL #: (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: UNK. CATHETER: (PROXIMAL CATHETER REV SEG) MODEL: 8596, SERIAL #: (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: UNK.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL WAS NOTED IN EVENT LOGS WITH NO MOTOR STALL RECOVERY. THE MOTOR STALL WAS CAUSED BY PATIENT HAVING MRI OR OTHER MEDICAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON THE DATE OF INITIAL REPORT, THE PATIENT HAD COME OUT OF THE MAGNETIC RESONANCE IMAGING (MRI) SCAN "ABOUT 45 MINUTES AGO, MAYBE 50 MINUTES AGO", AND THE PUMP WAS INTERROGATED "LIKE A MINUTE AGO" BEFORE THE REPORTER CALLED IN TO THE MANUFACTURER. IN ADDITION, IT WAS REPORTED THAT THE REPORTER HAD "STARTED INTERROGATING IT A HALF HOUR, 45 MINUTES AGO". IT WAS ALSO REPORTED THAT THE PATIENT WAS CLINICALLY DOING "OKAY" AT THE TIME OF THE INITIAL REPORT AND THAT BACLOFEN WAS BEING USED IN THE PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR