BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2983639 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03188
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 1, 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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP FOUND CORROSION, MOISTURE, AND RESIDUE THROUGHOUT THE GEAR-TRAIN. IT WAS FOUND THAT SOME OF THE TEETH OF GEAR WHEEL 3 WERE PARTIALLY CORRODED. RESIDUE WAS ALSO FOUND IN THE PINION OF GEARS 1 AND 2.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL WAS SEEN IN THE PATIENT'S PUMP LOGS WITHOUT A RECOVERY MESSAGE. ADDITIONALLY, A VOLUME DISCREPANCY WAS SEEN WITH AN EXPECTED RESERVOIR VOLUME OF 15.7ML, BUT AN ACTUAL RESERVOIR VOLUME OF 11.5ML. A FALSE MOTOR STALL WAS REPORTED, BUT THE REPORTER ADMITTED NOT KNOWING WHAT A FALSE MOTOR STALL WAS. AT THE TIME OF REPORT, THERE HAD BEEN NO PATIENT INJURY, SYMPTOMS, OR ADVERSE EVENT. ALSO, SALINE HAD BEEN PUT INTO THE RESERVOIR AND A MOTOR TEST WAS PLANNED. IF THE MOTOR WAS STALLED, THE PUMP WOULD BE EXPLANTED. A WEEK LATER, PUMP LOGS WERE SEEN THAT ALSO SHOWED A "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" MESSAGE TAKING PLACE TWO DAYS AFTER THE MOTOR STALL. THE DRUGS USED IN THIS SYSTEM WERE MORPHINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86646 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention