BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3092492 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07277
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 9, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP FOUND SIGNIFICANT CORROSION, RESIDUE, AND SHAFT WEAR ON THE UPPER SHAFT OF GEAR TWO. THERE WAS ALSO SOME RESIDUE ON THE JEWEL WHERE THE UPPER SHAFT OF GEAR TWO INSERTS INTO THE TOP BRIDGE ASSEMBLY. THERE WERE MULTIPLE MOTOR STALLS AND RECOVERIES SEEN IN THE LOGS AND THE STALLS WERE DUE TO SHAFT-BEARING.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709, LOT# L60026, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL OCCURRED ON (B)(6) AT 4:04PM AND DIDN'T RECOVER UNTIL 8:43PM ON (B)(6). THE PATIENT HEARD THE ALARM ON SATURDAY AND WENT TO THE EMERGENCY ROOM WITH UNDERDOSE SYMPTOMS ON SUNDAY MORNING. IT WAS REPORTED THAT THE PATIENT AND PHYSICIAN WERE WORKING ON SCHEDULING THE PUMP REPLACEMENT. THE DEVICE SYSTEM WAS DELIVERING MORPHINE AND BUPIVACAINE. THAT SAME DAY, IT WAS ALSO REPORTED THAT THE PATIENT FELT WITHDRAWAL. HE WENT TO THE HOSPITAL ON SUNDAY AND WAS GIVEN SOME SUPPLEMENTAL MEDICATIONS. THE PATIENT WAS IN THE HOSPITAL FOR A FEW HOURS AND FELT BETTER. AN APPOINTMENT WAS MADE TO HAVE THE PUMP LOGS READ. IT WAS SEEN THAT ONLY ONE STALL WAS RECORDED IN THE PUMP LOGS THAT DATED BACK TO (B)(6) 2012. THE PATIENT WAS FEELING FINE AT THE TIME OF REPORT. THREE WEEKS LATER, IT WAS REPORTED THAT THE REPLACEMENT WENT WELL. ADDITIONALLY, THE PATIENT WAS DOING WELL AT HIS FOLLOW-UP WITH HIS PHYSICIAN. THE NEXT DAY, IT WAS REPORTED THAT THE PUMP WAS ALARMING FOR A MOTOR STALL AND AN EMPTY RESERVOIR. THE REPORTER SILENCED THE ALARM, UPDATED THE ALARM VOLUME, AND CHANGED THE RESERVOIR VOLUME TO 10ML. IT WAS ALSO NOTED THAT SOME CALCIFICATION WAS SEEN AROUND THE CATHETER ACCESS PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194534 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention