BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 2032224 · Received March 18, 2011

    Report

    Report Number
    2032224
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 27, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAS A HISTORY OF NONISCHEMIC CARDIOMYOPATHY AND VENTRICULAR TACHYCARDIA, AS WELL AS OBESITY AND RENAL INSUFFICIENCY. SHE HAD A BIVENTRICULAR AUTOMATIC IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR PLACED IN 2007 AND A GENERATOR PLACED IN 2008. HER LEFT VENTRICULAR LEAD WAS DISLODGED AND LOCATED IN THE RIGHT ATRIUM AND WAS NONFUNCTIONAL. SHE UNDERWENT ATTEMPTED EXTRACTION OF THE LEFT VENTRICULAR LEAD 3 WEEKS AGO. THIS WAS NOT SUCCESSFUL. HER LEFT VENTRICULAR LEAD HAD BEEN IN THE RIGHT ATRIUM FOR SOME TIME AND WAS NONFUNCTIONING. SHE PRESENTED TO THE OPERATING ROOM FOR LASER EXTRACTION OF THE LEFT VENTRICULAR LEAD AND ATTEMPTED PLACEMENT OF A NEW LEFT VENTRICULAR PACING LEAD. UPON INSPECTING THE POCKET IT WAS NOTED THAT THERE WAS AN INSULATION BREAK IN THE RIGHT ATRIAL LEAD AND THEREFORE THIS WAS TRACED BACK TO ITS SUTURE GUARD. THE PATIENT RECOVERED FROM THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL SEVERAL DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST LEAD, PACEMAKER DTB ST. JUDE MEDICAL 1788T-52 *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR