BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 920875 · Received September 21, 2007

    Report

    Report Number
    6000030-2007-02892
    Event Type
    Injury
    Date Received
    September 21, 2007
    Report Date
    April 21, 2005
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED UNDER EXEMPTION NUMBER (B)(4) WHICH COVERS A 2-YEAR RETROSPECTIVE REVIEW OF REPORTED EVENTS INVOLVING CATHETERS AND EVENTS REPORTED BY CONSUMERS BETWEEN JANUARY 1, 2005 AND DECEMBER 31, 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 54 TOTAL UNREPORTED SERIOUS INJURY EVENTS FOR INTRATHECAL CATHETERS; 21 SERIOUS INJURY EVENTS FOR MODEL 8709, 12 SERIOUS INJURY EVENTS FOR MODEL 8731, 10 SERIOUS INJURY EVENTS FOR MODEL 8709AA, 5 SERIOUS INJURY EVENT FOR MODEL 8703W, 3 SERIOUS INJURY EVENT FOR MODEL 8711, 2 SERIOUS INJURY EVENTS FOR MODEL 8703, AND 1 SERIOUS INJURY EVENT FOR MODEL CATHETER FOR THE ABOVE TIME PERIOD (ALL PRODUCT CODE LKK). THIS TOTAL INCLUDES THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED VIA A PATIENT SURVEY THAT THE NEUROSURGEON WHO WORKED WITH HER PAIN SYSTEM CAUSED A SPINAL INJURY (DETAILS UNKNOWN) AND REPORTED, IT HAS TAKEN HER A YEAR TO LEARN HOW TO WALK AGAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE HCP WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709AA J11564R19

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability