BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 2013927 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01699
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 27, 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 PATIENT UNDERWENT BYPASS SURGERY ON (B)(6) 2010. DEVICE TESTING AFTER THE PROCEDURE FOUND LOSS OF CAPTURE ON THE RIGHT VENTRICULAR LEAD. A CHEST X-RAY REVEALED THAT THE LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED; LEAD INSULATION DAMAGE WAS NOTED. IT WAS SUSPECTED THAT THE CANNULATION PROCEDURE DURING THE BYPASS LIKELY CAUSED THE LEAD DAMAGE AND DISLODGEMENT.

    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/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention