BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 596468 · Received April 26, 2005

    Report

    Report Number
    6000030-2005-00655
    Event Type
    Injury
    Date Received
    April 26, 2005
    Date of Event
    April 15, 2005
    Report Date
    April 15, 2005
    Manufacturer
    RICE CREEK 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

    THE HCP REPORTED THAT FOLLOWING REFILL, THE PATIENT EXPERIENCED AN OVERDOSE. FOLLOWING PUMP REFILL, THE PATIENT COMPLAINED OF A "BACKACHE". APPROXIMATELY 45 MINUTES AFTER REFILL, THE PATIENT WAS FOUND UNRESPONSIVE, BLOOD PRESSURE WAS ELEVATED, LEFT PUPIL WAS DILATED AND HEART RATE WAS 150. THE PUMP WAS STOPPED. THE HCP PERFORMED A LUMBAR PUNCTURE ASPIRATING 35 CCS OF SPINAL FLUID, FOLLOWING STANDARD OVERDOSE PROCEDURES. OXYGEN WAS ADMINISTERED AND THE BLOOD PRESSURE DECREASED. THE HCP INDICATED THAT THE 'WRONG KIT" WAS USED; "I FILLED THE SIDE PORT". THE PATIENT RECEIVED 16-17 CCS THROUGH THE CATHETER. THE PATIENT WAS MONITORED CLOSELY. A FOLLOW-UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE TO CO.

    Description of Event or Problem · 1

    FACILITY MEDWATCH # 230130 2005 0001 ATTACHED. PT IDENTIFIER: 1149012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEK MANUFACTURING 862718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R EXPLANTED:UNK.| CATHETER:MODEL 8711, LOT#J0177978R, IMPLANTED:2001