BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRHOMED II

    MDR report key: 1902260 · Received November 15, 2010

    Report

    Report Number
    3004209178-2010-09473
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 30, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED WITH SYMPTOMS OF OVERDOSE. THE PATIENT WAS "VERY SLEEPY." THIS HAD BEEN HAPPENING ON AND OFF FOR APPROXIMATELY SIX MONTHS. THE PUMP LOGS WERE READ AND WERE NORMAL. NO VOLUME DISCREPANCIES WERE NOTED. IT WAS STATED THAT THE CHANGE IN THERAPY HAD BEEN AN ONGOING ISSUE DESPITE A TOTAL SYSTEM REPLACEMENT IN OCTOBER AFTER THE CATHETER HAD BEEN EVALUATED BY A CAP STUDY AND SPIRAL CT WITH CONTRAST. THE HEALTH CARE PROFESSIONAL REPORTED OVERDOSE/UNDERDOSE SYMPTOMS 4-6 DAYS POST DAILY DOSE ADJUSTMENT. IT WAS NOTED THAT THE PATIENT ENDED UP IN THE EMERGENCY ROOM WITH SOME OF THE DOSE ADJUSTMENTS DUE TO SEVERE SYMPTOMS. THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRHOMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N140788003| IMPLANTED:| EXPLANTED: