BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 485581 · Received September 23, 2003

    Report

    Report Number
    6000030-2003-00869
    Event Type
    Injury
    Date Received
    September 23, 2003
    Date of Event
    August 22, 2003
    Report Date
    September 22, 2003
    Manufacturer
    RICE CREEEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A PUMP REPLACEMENT (2003), SALINE WAS INSTILLED INTO THE PUMP BECAUSE THERE WAS NO MEDICATION ORDERED PRIOR TO THE SCHEDULED PROCEDURE. THE PATIENT PRESENTED WITH SYMPTOMS OF WITHDRAWL 2 DAYS LATER INCLUDING PAIN, HEADACHES, AND ANXIETY. THE PUMP WAS THEN FILLED 2 DAYS LATER WITH THE PRESCRIBED PUMP MEDICATION. ONCE THE PUMP WAS FILLED PROPERLY, THE PATIENT WAS REPORTED AS DOING BETTER. THEIR PAIN IS UNDER CONTROL AND THEIR BRUISING FROM THE SURGERY HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other CATHETER MODEL 8709 LOT# J11507R14 IMPLANTED: 2003| EXPLANTED: UNK.