BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3030498 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04466
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF FEVER AND TENDERNESS IN THE PUMP POCKET. THE HEALTH CARE PROVIDER (HCP) EXAMINED THE PUMP POCKET AREA AND CONFIRMED ERYTHEMA, PURULENT AND A LESION AT THE SCAR FROM THE PUMP IMPLANT. AN INFECTION DEVELOPED IN THE PUMP POCKET AREA WITH SECONDARY TRUNCAL CELLULITIS AND POSSIBLE ABSCESS. THIS WAS REPORTED TO BE POSSIBLY RELATED TO THE DEVICE OR THERAPY. THE PUMP WAS INTERROGATED WITH NORMAL RESULTS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ADMINISTERED INTRAVENOUS (IV) VANCOMYCIN. THE PUMP POCKET AREA WAS DRAINED AND AN ATTEMPT WAS MADE TO ASPIRATE THE LESION WITH NO DRAINABLE ABSCESS. SCREENING FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) WAS NEGATIVE AS THE WOUND CULTURE PRODUCED NO GROWTH AFTER TWO DAYS. HOWEVER, THE WOUND CULTURE WAS POSITIVE FOR STAPHYLOCOCCUS AND THIS WAS REPORTED AS THE ONLY MICROORGANISM PRESENT. THE PATIENT WAS ADMINISTERED ORAL BACTRIM FOR SEVEN DAYS POST HOSPITAL DISCHARGE. IT WAS LATER REPORTED THAT THE PATIENT WAS READMITTED TO THE HOSPITAL FOR AN ADDITIONAL ROUND OF IV VANCOMYCIN. THE PUMP POCKET AREA STILL HAD REDNESS AND DISCHARGE THAT DID NOT RESOLVE WITH THE ORIGINAL IV AND ORAL ANTIBIOTICS. ADDITIONAL LABORATORY RESULTS WERE ALSO PROVIDED: WHITE BLOOD CELL COUNT OF 4.3K/CMMM, HEMOGLOBIN OF 11.8 G/DL, HEMATOCRIT 35.7%, AND A PLATELET COUNT OF 273 K/CMM. THIS DEVICE SYSTEM DELIVERED MORPHINE. THE OUTCOME OF THE EVENT WAS REPORTED AS ONGOING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THE PUMP WAS EXPLANTED DUE TO THE PUMP POCKET INFECTION. THERE WAS NO PERFORMANCE ISSUE WITH THE DEVICE. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135198 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R