BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3200064 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-04777
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    February 18, 2007
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8703W, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER; PRODUCT ID NE U_UNKNOWN_PROG, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ALTERED MENTAL STATUS, HALLUCINATIONS AND CONFUSION. ALL PROGRAMMING AND EVENT LOGS WERE VERIFIED AS CORRECT. NO MOTOR STALLS, MEMORY ERRORS, ETC. THE HEALTH CARE PROVIDER STATED LAST REFILL WAS APPROXIMATE 1 MONTH PRIOR TO THE CALL. THE PATIENT WAS ON OTHER ORAL DRUGS AS WELL. THE PATIENT HAD RADIOLOGY. THE DRUGS DELIVERED IN THE PUMP WERE FENTANYL AND BACLOFEN. THE PATIENT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298112 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Other