BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1830822 · Received September 8, 2010

    Report

    Report Number
    3004209178-2010-06871
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN OVERDOSE WITH THE SYMPTOM OF "UNRESPONSIVE." THIS OCCURRED DURING THE NORMAL REFILL CYCLE. PATIENT WAS SEEN IN THE EMERGENCY ROOM IN THE PAST WEEK WITH ASSOCIATED SYMPTOMS. PUMP PROGRAMMING WAS CHANGED TO THE MINIMUM RATE MODE. THE PATIENT'S CONDITION IMPROVED. REPORTER WAS UNSURE OF THE ETIOLOGY OF THE OVERDOSE SYMPTOMS. PATIENT WAS BACK TO THE OFFICE ON (B)(6), 2010 TO HAVE THE PUMP PROGRAMMED TO A THERAPEUTIC RATE DUE TO THE RETURN OF HIS PAIN BUT THE CONCENTRATION IS TOO HIGH TO DELIVER AT THE DOSE NEEDED. A REFILL WAS TO BE DONE AT A LOWER CONCENTRATION. ON (B)(6), 2010, IT WAS REPORTED THAT THERE WAS DIFFICULTY ASPIRATING FLUID THROUGH THE CATHETER ACCESS PORT (CAP). A 0.191 CATHETER VOLUME AND A 0.289 PUMP TUBING VOLUME, A TOTAL VOLUME OF 0.48 DIVIDED 0.006 PER DAY EQUALED 80 DAYS TO CLEAR THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 44 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT # N243803002