BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE FIXATION ENDOCARDIAL LEAD

    MDR report key: 103206 · Received March 10, 1997

    Report

    Report Number
    2017865-1997-00452
    Event Type
    Injury
    Date Received
    March 10, 1997
    Date of Event
    December 19, 1996
    Manufacturer
    PACESETTER INC.
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 LEAD DISLODGEMENT AND THAT THE "LEAD FOUND TO BE OUTSIDE OF HRT."~~~~~~~~~

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVE FIXATION ENDOCARDIAL LEAD Implant PERMANENT PACEMAKER ELECTRODE DTB PACESETTER INC. 1188T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention