BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203534 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-04571
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    October 10, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(60 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ALARM CONFIRMED BY TELEMETRY DUE TO A MOTOR STALL. THE ALARM WAS HEARD AS THE PUMP WAS BEING INTERROGATED IN PREPARATION FOR A REFILL. THE PATIENT HAD A MAGNETIC RESONANCE IMAGE (MRI) THE DAY BEFORE BUT WAITED TO HAVE THE PUMP CHECKED UNTIL THE DAY OF THIS REPORT. THE MOTOR STALL OCCURRED AT 09:55 ON (B)(6) 2012 AND RECOVERED AT 10:42 ON (B)(6) 2012. IT WAS LATER REPORTED THE MRI WAS 3 HOURS. TELEMETRY SHOWED THAT A MOTOR STALL OCCURRED, BUT THE PUMP WAS WORKING FINE. THERE WERE NO VOLUME DISCREPANCIES OR ISSUES. THE PATIENT WAS ASYMPTOMATIC. THE HEALTH CARE PROVIDER WAS ABLE TO REFILL THE PUMP FINE. THE PATIENT WAS SEEN (B)(6) 2012 FOR ANOTHER REFILL AND THERE WERE NO VOLUME DISCREPANCIES OR ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306169 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR