BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND XT 4CH COMBO PKG

    MDR report key: 1082280 · Received July 25, 2008

    Report

    Report Number
    1022819-2008-00183
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    PMA / PMN Number
    K031077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TYPE OF DEVICE: IMG, GZJ, GZI. AWAITING DEVICE RETURN AND EVALUATION. CHATTANOOGA GROUP TOOK ACTION TO HAVE THE DEVICE RETURNED FOR EVALUATION AND REPAIRS IF REQUIRED.

    Description of Event or Problem · 1

    FDA RECALL FIELD CORRECTION EFFECTIVENESS CHECK. THE FDA CONDUCTED ROUTINE EFFECTIVENESS INSPECTIONS OF THE DEVICES TO INSURE THAT THE DEVICE HAD BEEN UPDATED WITH THE SOFTWARE ISSUED OF THE RECENT RECALL FIELD CORRECTION. THE FDA DEEMED THAT THE DEVICES HAD NOT BEEN UPDATED. THE POTENTIAL FOR PT SKIN BURN AND/OR SHOCK EXIST, DUE TO THE RECALL/FIELD CORRECTION SOFTWARE NOT BEING INSTALLED. THIS POTENTIAL ADVERSE EVENT AND/OR PRODUCT PROBLEM COULD RESULT IN A PT INJURY. NO INJURY/ADVERSE EVENT OCCURRED TO A PT. CHATTANOOGA GROUP WAS NOTIFIED OF THE FDA FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND XT 4CH COMBO PKG IPF CHATTANOOGA GROUP 27233

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability