BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1834604 · Received September 9, 2010

    Report

    Report Number
    3004209178-2010-06901
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 18, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE ACTUAL RESIDUAL VOLUME OF 12 ML WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME OF 4.6 ML. THE PATIENT WAS SOMEWHAT "FLOPPY" ON (B)(6) 2010. THE PATIENT HAD HAD NO FAILS OR TRAUMA, NOR HAD THEY HAD AN MRI. A MOTOR STALL WAS NOT NOTED IN THE PUMP LOGS. IN LATER REPORTING FROM (B)(6) 2010 IT WAS NOTED THERE WAS A VOLUME DISCREPANCY WITH THE ACTUAL RESIDUAL VOLUME BEING LESS THAN THE EXPECTED RESIDUAL VOLUME. "THE HCP WAS EXPECTING 12 CC AND GOT ZERO." AT THE LAST REFILL, THEY WERE EXPECTING 12 CC AND GOT 8 CC. IT WAS BELIEVED THAT ALL THE DRUG WENT INTO THE PUMP AT THE LAST REFILL, BUT IT WAS NOTED THAT THE PATIENT'S PUMP WAS DIFFICULT TO REFILL DUE TO EXCESS WEIGHT. ON (B)(6) 2010 ,ANOTHER REPORTER NOTED THE ACTUAL RESIDUAL VOLUME OF 12 ML BEING GREATER THAN THE EXPECTED RESIDUAL VOLUME OF 4.6 ML. THE PATIENT EXPERIENCED WITHDRAW ON (B)(6) 2010 AND WAS EXPERIENCING PRURITUS. THE EVENT OCCURRED DURING A NORMAL REFILL CYCLE. THE PATIENT'S PUMP WAS REFILLED ON (B)(6) 2010. IT WAS NOTED THAT THEY HAD HAD DIFFICULTY ACCESSING THE PATIENT'S PUMP FOR REFILLS IN THE PAST. IT WAS POSSIBLE THERE WAS A POCKET FILL OR PARTIAL POCKET FILL ON (B)(6) 2010. THE PUMP CONTAINED 2000 MCG/ML LIORESAL WITH A DOSE OF 718.4 MCG/DAY. THE PATIENT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N161756004| ACCESSORY: MODEL 8590-1, LOT# N161276