BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE FIXATION ENDOCARDIAL LEAD

    MDR report key: 152685 · Received February 6, 1998

    Report

    Report Number
    2017865-1998-00009
    Event Type
    Injury
    Date Received
    February 6, 1998
    Date of Event
    September 16, 1997
    Report Date
    September 30, 1997
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES SENSING DIF FICULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVE FIXATION ENDOCARDIAL LEAD Implant PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1188T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention