BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1120756 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-04960
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS CODE USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPY. THE NON-CRITICAL ALARM WAS HEARD AND CONFIRMED BY TELEMETRY AND WAS DETERMINED THAT THE PUMP HAD NOT BEEN UPDATED. THE PUMP CONTAINED MORPHINE (PF MORPHINE SULFATE) AND BUPIVAICAINE (MARCAINE). A DYE STUDY WAS ATTEMPTED; THE PT WAS SUBSEQUENTLY TAKEN TO SURGERY AND THE DISTAL PORTION OF THE CATHETER WAS REPLACED. THE CATHETER HAD COILED UP AND PULLED OUT OF THE INTRATHECAL SPACE. THE HCP BELIEVED THAT THE PT MAY HAVE FLIPPED THE PUMP MULTIPLE TIMES CAUSING THE CATHETER TO COIL. THE PT HAS BEEN DOING "OKAY" SINCE THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8731SC| EXPLANTED| PROGRAMMER MODEL 8840