BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 920874 · Received September 21, 2007

    Report

    Report Number
    6000030-2007-02811
    Event Type
    Injury
    Date Received
    September 21, 2007
    Report Date
    September 12, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION, WHICH COVERS A 2-YEAR RETROSPECTIVE REVIEW OF REPORTED EVENTS INVOLVING CATHETERS AND EVENTS REPORTED BY CONSUMERS BETWEEN 2005 AND LATE 2006 (INCLUSIVE). THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY, DEATH AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS THE PREVIOUSLY UNREPORTED SERIOUS INJURY EVENTS FOR SYNCHROMED PUMPS; UNREPORTED SERIOUS INJURY EVENTS FOR MODEL 8627L18, SERIOUS INJURY EVENTS FOR MODEL 863720, SERIOUS INJURY EVENTS FOR MODEL 863740, SERIOUS INJURY EVENTS FOR MODEL 862718, SERIOUS INJURY EVENTS FOR MODEL PUMP, 2 SERIOUS INJURY EVENTS FOR MODEL 862618, 2 SERIOUS INJURY EVENTS FOR MODEL 8627L10, SERIOUS INJURY EVENT FOR MODEL 861618, SERIOUS INJURY EVENT FOR MODEL 861718, SERIOUS INJURY EVENT FOR MODEL 862710, AND SERIOUS INJURY EVENT FOR MODEL 8637 FOR THE ABOVE TIME PERIOD (ALL PRODUCT CODE LKK). THIS TOTAL INCLUDES THE EVENT DESCRIBED IN THIS REPORT. (SEE THE ATTACHED SUMMARY REPORT FOR A LISTING OF ALL EVENTS.) SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE PUMP WAS REMOVED DUE TO AN INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention CATHETER MODEL 8709AA LOT# J11336R63| EXPLANTED: | IMPLANTED: | CATHETER MODEL 8709AA LOT# J11336R63| IMPLANTED:| EXPLANTED: