BEUDAMED
    FDA Adverse Event Other Summary report: N

    MARQUIS DR

    MDR report key: 697498 · Received March 13, 2006

    Report

    Report Number
    697498
    Event Type
    Other
    Date Received
    March 13, 2006
    Date of Event
    February 28, 2006
    Report Date
    March 13, 2006
    Manufacturer
    MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    POCKET FOR ICD BECAME ACUTELY INFLAMED. THE POCKET HAD A 4CM-LONG ERODED SEGMENT THAT HAD TO BE REMOVED. THE ICD WAS ONE THAT HAD A RECALL ADVISORY SO IT WAS REPLACED AT SAME TIME POCKET EROSION WAS EXCISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS DR ICD LWS MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT 7274 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR