BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSAFE ENDOCARDIAL PACING LEAD

    MDR report key: 58133 · Received December 19, 1996

    Report

    Report Number
    2522457-1996-00007
    Event Type
    Injury
    Date Received
    December 19, 1996
    Date of Event
    November 21, 1996
    Report Date
    November 21, 1996
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC.
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 11/19/96, AN 81 YR OLD MALE PT WAS IMPLANTED WITH A SINGLE-LEAD ATRIAL SYNCHRONOUS VENTRICULAR PACEMAKER SYSTEM. ON 11/20/96, THE ABOVE REFERENCED PT PRESENTED WITH LOSS OF ATRIAL SENSING. ON 11/21/96, THE PHYSICIAN ELECTED TO REOPEN THE PACEMAKER POCKET AND HE OBSERVED THE LEAD WAS INCOMPLETELY INSERTED INTO THE PACEMAKER CONNECTOR CAVITY. PACEMAKER WAS CLEANED, LEAD CONNECTORS REINSERTED, SET-SCREWS TIGHTENED AND COMPLICATION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSAFE ENDOCARDIAL PACING LEAD Implant PACING LEAD DTB CARDIAC CONTROL SYSTEMS, INC. AT-443 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization