BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE 2 EZ

    MDR report key: 783720 · Received November 9, 2006

    Report

    Report Number
    2124215-2006-17581
    Event Type
    Injury
    Date Received
    November 9, 2006
    Date of Event
    August 2, 2006
    Report Date
    August 2, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS UNABLE TO CAPTURE. LEAD DISLODGEMENT WAS SUSPECTED BUT NOT CONFIRMED. TESTING REVEALED NO IMPEDANCE OR THRESHOLD ISSUES. ISOMETRICS WAS ABLE TO ELICIT LOSS OF CAPTURE. THE LEAD WAS EXPLANTED AND DURING THE EXPLANT, BLOOD WAS NOTED IN THE LEAD BODY. THE PHYSICIAN QUESTIONED WHETHER THE LEAD WAS DAMAGED, RESULTING IN THE BLOOD INFILTRATION AND IF THIS AFFECTED THE LEAD'S ABILITY TO CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE 2 EZ IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 438-35S-58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention