BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2231095 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06901
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT SHOWED SIGNS OF INFECTION, HIGH FEVER AND FLUID WAS DRAINING FROM THE ABDOMINAL INCISION SITE. ON (B)(6) 2011, THE PT WENT TO THE EMERGENCY ROOM. PUMP AND CATHETER WERE EXPLANTED THE NEXT DAY. THE PT WAS AGGRESSIVELY TREATED WITH ANTIBIOTICS. THE PT WAS ADMITTED TO THE HOSPITAL TO OBSERVE FOR POTENTIAL WITHDRAWAL. IT WAS LATER REPORTED THAT "PUMP CATHETER SYSTEM INFECTION" WAS SUSPECTED. A SMALL AMOUNT OF SEROSANGUINOUS FLUID WAS LEAKING FROM ABDOMINAL WOUND. AN ADDITIONAL CSF CULTURE WAS PERFORMED ON (B)(6) 2011; AS OF (B)(6) 2011 CULTURE RESULT WAS PENDING. THE PT WAS HOSPITALIZED FROM (B)(6) 2011 TO (B)(6) 2011. THE PT THEN DISCHARGED TO A SKILLED NURSING FACILITY IN "STABLE" CONDITION. THE DRUG DELIVERED WAS LIORESAL 500 MCG/ML AT THE DAILY DOSE OF 290.42 MCG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N283302005