BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE FIXATION LEAD

    MDR report key: 119310 · Received July 11, 1997

    Report

    Report Number
    2017865-1997-00804
    Event Type
    Injury
    Date Received
    July 11, 1997
    Date of Event
    April 16, 1997
    Report Date
    April 24, 1997
    Manufacturer
    PACESETTER INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE FIELD NOTES A VENTRICULAR LOSS OF CAPTURE. THE PATIENT HAD COMPLETE HEART BLOCK FOLLOWING AV J UNCTIONAL ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVE FIXATION LEAD Implant PERMANENT PACEMAKER ELECTRODE DTB PACESETTER INC. 1148T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention