BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2933337 · Received January 29, 2013

    Report

    Report Number
    3004209178-2013-01081
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8 590-1, LOT# N099338, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN INFECTION IN THE DEVICE POCKET OCCURRED. SURGICAL INTERVENTION WAS REQUIRED; THE WOUND POCKET WAS CLEANED AND THE MESH POUCH WAS REMOVED. THE PUMP REMAINED IMPLANTED. A CULTURE WAS OBTAINED FROM THE DEVICE POCKET HOWEVER THE RESULTS WERE NOT PROVIDED. IT WAS REPORTED ANTIBIOTIC TREATMENT WAS NECESSARY. THE SYMPTOM THE PATIENT EXPERIENCED WAS A FEVER. AT THE TIME OF THIS REPORT THE PATIENT'S STATUS WAS NOT KNOWN TO THE REPORTER. THE DRUG BEING DELIVERED VIA THE DEVICE SYSTEM WAS UNKNOWN TO THE REPORTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS HEALING WELL AND WAS PROGRESSING IN THE RIGHT DIRECTION. THE PATIENT WAS RECENTLY SEEN BY THE PHYSICIAN AND THE PHYSICIAN WAS HAPPY WITH HOW THINGS WERE GOING. IT WAS ALSO REPORTED THAT PATIENT DID NOT HAVE MENINGITIS. THE DRUG IN THE PUMP WAS REPORTED AS "NOT APPLICABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39426 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention