BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3070734 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06633
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 25, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8703W LOT# L43745, IMPLANTED: 1997 (B)(6), PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO SIGNIFICANT ANOMALY FOUND. ANALYSIS OF THE CATHETER REVEALED NO SIGNIFICANT ANOMALY; CATHETER INCOMPLETE, RETURNED IN SEGMENTS; ACCEPTABLE TESTING. (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 LATER REPORTED THAT THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN AND CLONIDINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN "ALLERGIC REACTION/EROSION" OCCURRED AT THE INFERIOR PUMP POCKET SITE. THE PUMP WAS EXPLANTED AND THE CATHETER WAS CUT OFF AND THE POCKET TIED. IT WAS STATED, THE PHYSICIAN FELT THE POCKET DID NOT APPEAR TO BE INFECTED AND CULTURES WERE PENDING. IT WAS ALSO NOTED, THE PATIENT DID RECEIVE ANTIBIOTICS. THE CULTURE WAS NEGATIVE AS OF (B)(6) 2013. FOLLOWING THE EXPLANT, WOUND CARE WAS EXECUTED EVERY OTHER DAY, TO HELP HEAL THE POCKET. THE PATIENT WAS MANAGED FOR PAIN AND WITHDRAWAL AND HIS STATUS WAS REPORTED AS "TOLERATING". THE MEDICATION BEING DELIVERED WAS INITIALLY REPORTED AS SOLELY MORPHINE. THE RETURNED PRODUCT WAS RECEIVED AND THE PUMP LOGS REVEALED THE MEDICATIONS PROGRAMMED WERE MORPHINE, LIORESAL AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171066 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention