BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4242687 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21291
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 22, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (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

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP SERIAL NUMBER (B)(4) FOUND NO ANOMALY. ANALYSIS OF THE CATHETER SERIAL NUMBER (B)(4) FOUND CATHETER BODY HOLE CAUSED BY DEEP ABRASION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED FEVER AND INCREASED PERSISTENT BACK PAIN. THE PUMP POCKET IN THE LEFT UPPER GLUTEUS WAS UNREMARKABLE TO COLOR OR SWELLING. A LARGE CARBUNCLE WAS NOTED AT THE RIGHT LOWER GLUTEUS. THE WHITE BLOOD CELL (WBC) COUNT WAS ELEVATED. MEDICAL INTERVENTION WAS ANTIBIOTIC THERAPY. THE DEVICE WAS EXPLANTED DUE TO AN INFECTION OF UNKNOWN ORGANISM. THE PATIENT WAS HOSPITALIZED. PATIENT STATUS AT TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS DELIVERING HYDROMORPHONE AND BUPIVICAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726336 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R