BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2971849 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02938
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 28, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP WAS BEING REPLACED DUE TO MULTIPLE VOLUME DISCREPANCIES AT REFILLS. SPECIFICALLY, IT WAS STATED THAT THE EXPECTED RESIDUAL VOLUME WAS 2ML, BUT THE ACTUAL RESIDUAL VOLUME WAS 8ML. IT WAS ALSO NOTED THAT THE PHYSICIAN HAD ATTEMPTED TO ASPIRATE THE CATHETER WITH MINIMAL RETURN, LESS THAN 0.1CC. IT WAS NOTED THAT AT THE REPLACEMENT SURGERY, THE CATHETER WAS LEFT INTACT AND A "BACK TABLE PRIME OF 0.3" WAS PERFORMED. AT THE TIME OF REPORT, THERE WERE NO PATIENT SYMPTOMS, INJURIES, OR ADVERSE EVENTS RELATED TO THIS EVENT. THE DRUG USED IN THIS SYSTEM WAS LIORESAL.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE CATHETER WAS NOT REPLACED AND COULD NOT BE ASPIRATED. IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS A DYSFUNCTIONAL PUMP BATTERY DUE TO NORMAL BATTERY DEPLETION. THE PUMP WAS REPLACED. THE CATHETER PATENCY ISSUE WAS RESOLVED. THE PATIENT EXPERIENCED INCREASED MUSCLE SPASMS. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76743 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention