BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1050506 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01482
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 1, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT, CAPTURE THRESHOLDS ROSE ACUTELY FROM 0.6 V TO 1.5 V IN BOTH CONFIGURATIONS. WHILE IN RECOVERY, THE PATIENT EXPERIENCED TORSADES DE POINTES AND CHEST COMPRESSIONS WERE PERFORMED. ECHOCARDIO- GRAM AND X-RAY DID NOT REVEAL A PERFORATION OR DISLODGEMENT. THE LEAD WAS REMOVED FROM THE RIGHT VENTRICULAR APEX AND REPOSITIONED IN THE TRICUSPID VALVE SEPTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention