BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3955406 · Received July 24, 2014

    Report

    Report Number
    3004209178-2014-13484
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    May 25, 2014
    Report Date
    June 27, 2014
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER. (B)(4). RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP, SERIAL NUMBER (B)(4), FOUND MISCELLANEOUS ALARM ANOMALY OF AN UNDETERMINED CAUSE. INTERROGATION OF THE PUMP FOUND IT WAS USED TO INFUSE MORPHINE, BUPIVACAINE, CLONIDINE AND BACLOFEN.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE PUMP SERIAL NUMBER (B)(4) RESULTED IN A CHANGE OF THE ANALYSIS FINDING FROM ¿ALARM ANOMALY WITH UNDETERMINED ROOT CAUSE¿ TO A ¿NO ANOMALY¿ FINDING. ALARM TESTING GUIDANCE WAS UPDATED AND NO ANOMALY WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT 20ML OF DRUG WAS FILLED ON 2013 (B)(6), AND ON 2014 (B)(6) 12.7ML OF FLUID WAS ASPIRATED. IT WAS STATED THAT BASED ON THEIR CALCULATIONS, THEY FELT THE PUMP SHOULD HAVE BEEN EMPTY OR NEAR EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433420 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR