BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3030799 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04473
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 4, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ANALYSIS OF THE PUMP REVEALED PUMP MOTOR GEAR TRAIN ANOMALY; CORROSION AND/OR WEAR AND/OR LUBRICATION. (B)(4).

    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 THAT THE PATIENT HAD INCREASING PAIN, AND INTERROGATION SHOWED MOTOR STALL. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY. NO FURTHER TROUBLESHOOTING WAS PERFORMED. THE PATIENT WAS GIVEN ORAL MORPHINE TREATMENT. A REPLACEMENT WAS PERFORMED AND AFTERWARD THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. THE DEVICE SYSTEM WAS BEING USED TO DELIVER MORPHINE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED ORAL MORPHINE MEDICATION TO SUBSTITUTE THE MISSING INTRATHECAL DRUG DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133553 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention