BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3844137 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09997
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 15, 2014
    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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP SN (B)(4) FOUND A HOLE IN THE PUMP TUBE FROM MECHANICAL WEAR. THERE WAS CORROSION ON GEAR WHEEL 3. (B)(4)

    Additional Manufacturer Narrative · 1

    ANALYSIS 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS EXPLANTED. IT WAS REPORTED THE PUMP CONTINUED TO MOTOR STALL OVER 7-10 DAYS. THE PUMP WAS USED TO DELIVER DILAUDID, CLONIDINE, HYPNOVEL, AND XYLOCARD. THE PATIENT STATUS WAS NOTED AS FULLY RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE FOR THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER PROVIDED THAT APART FROM THE MOTOR STALLING, THERE WAS NOT ANY OTHER CAUSE OR ISSUE TO EXPLAIN WHY THIS OCCURRED. THE PATIENT¿S LOGS INDICATED THE PUMP ALARM WAS HEARD SEVERAL TIMES BETWEEN (B)(6) WHILE THE PATIENT WAS IN A CHAIR, IN BED, ON LOUNGE, AT THE COMPUTER AND WITH NOTED TV AND AIR ON AT ONE POINT. THE PATIENT WAS CURRENTLY DOING ¿OK¿ AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321985 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention