BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 2013929 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01663
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 21, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW HOURS POST IMPLANT, THE ATRIAL LEAD EXHIBITED A DROP IN P-WAVE AMPLITUDE AND A DRAMATIC INCREASE IN CAPTURE THRESHOLD. CARDIAC PERFORATION WAS SUSPECTED. A PERICARDIAL EFFUSION WAS PERFORMED. THE LEAD WAS SUCCESSFULLY REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2088TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention