BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3241140 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12103
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8782, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8784, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A DEVICE EXPLANT DUE TO INFECTION. THE REPORTER WAS NOTIFIED BY THE HEALTH CARE PROVIDER (HCP) ON (B)(6) 2013 THAT AN INFECTION WAS SUSPECTED, AND THEN THE INFECTION WAS CONFIRMED AND DEVICE EXPLANTED ON (B)(6) 2013. ALL DEVICE COMPONENTS WERE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE INFECTION ONSET/DIAGNOSIS WAS ON (B)(6) 2013. THE PATIENT EXPERIENCED REDNESS AND SWELLING. THE LOCATION OF THE INFECTION WAS THE DEVICE POCKET. A CULTURE WAS OBTAINED FROM THE DEVICE POCKED AND REVEALED VERY LIGHT GROWTH OF (B)(6). ORAL AND INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED. THE INFECTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340368 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention