BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3241428 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12124
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004: PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011: PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. TELEMETRY CONFIRMS A CRITICAL ALARM IS OCCURRING. RESET OCCURRED - LOW BATTERY. THERE WERE MULTIPLE MOTOR STALLS AND RECOVERIES BEGINNING ON (B)(6) 2013. A LOW BATTERY RESET OCCURRED ON (B)(6) 2013. A MOTOR STALL OCCURRED 6-1. A MOTOR STALL AND RECOVERY OCCURRED 6-3; STOPPED PUMP PERIOD 6-3. IT WAS CONFIRMED THE PUMP IS IN MINIMUM RATE. THE RESERVOIR VOLUME WAS 37.9ML. THE PUMP WAS FULL FROM BEING STALLED IN (B)(6) 2013. THE PATIENT WAS DOING FINE CLINICALLY. THE PATIENT WANTED THE PUMP AT MINIMUM RATE UNTIL WINTER. THE PATIENT DID NOT CURRENTLY NEED THE PUMP. THE PUMP WAS DELIVERING HYDROMORPHONE AND BUPIVACAINE. IT WAS LATER REPORTED THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2013 FOR A PUMP REFILL. ON ACCESSING THE PUMP IT WAS ASPIRATED AND THE VOLUME HAD NOT CHANGED SINCE THE PATIENT¿S VISIT ON (B)(6) 2013. THE EXPECTED VOLUME WAS 37.9ML THE ACTUAL VOLUME WAS 39ML. THE PUMP WAS REFILLED. THE PUMP WAS INTERROGATED AND REPROGRAMMED. THE LOGS REVEALED MULTIPLE MOTOR STALLS WHICH HAVE RESTARTED AT (B)(6) 2013 AND WAS PLACED INTO A SAFE STATE AND (B)(6) 2013. THERE WERE MOTOR STALLS ON (B)(6) 2013, (B)(6) 2013 AND SEVERAL OTHER TIMES. IT WAS INDICATED THE PATIENT HAD A PUMP MALFUNCTION ¿A NUMBER OF TIMES.¿ IT WAS INDICATED THAT THE PUMP WAS NOT FUNCTIONING. THE PUMP HAD REVERTED TO A MINIMUM RATE AND THE PATIENT HAD NOT BEEN RECEIVING MEDICINE. THE PATIENT EXPERIENCED DIARRHEA, MEMORY LOSS, NUMBNESS, BALANCE PROBLEMS, UNSTEADINESS, WEAKNESS, ANXIETY, (B)(6) EXPOSURE AND EXCESSIVE URINATION. THE PATIENT EXPERIENCED PAIN IN HIS BACK AND BILATERAL ANKLES/FEET. THE PATIENT¿S PAIN/SPASTICITY WAS INTERMITTENT AND IMPROVING. THE PATIENT USES A WHEELCHAIR CONSTANTLY. THIS HAS HELPED WITH HIS PAIN WHEN HE DOESN¿T HAVE TO WALK. THE PATIENT HAD NOT BEEN HAVING SIGNIFICANT PAIN WHICH WAS NOT UNUSUAL FOR HIM IN THE SUMMERTIME. THE PATIENT CHOOSES NOT TO HAVE ANYTHING DONE AND WOULD LIKE TO LEAVE THE PUMP AT A MINIMUM RATE TO SEE IF HE NEEDS IT IN THE WINTER. SATISFACTION WITH THE THERAPY WAS ¿EXCELLENT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341329 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR