BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 2240139 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05620
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 14, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS REVEALED THAT THE PROXIMAL INSULATION WAS ABRADED FROM 46.5 CM TO 47 CM, DUE TO FRICTION WITH ANOTHER IMPLANTABLE DEVICE, WHICH COULD HAVE CAUSED THE REPORTED THRESHOLD AND IMPEDANCE ANOMALIES.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT ONE HOUR POST PACEMAKER CHANGE- OUT, THE PATIENT RETURNED TO THE OPERATING ROOM DUE TO PASSING OUT AND BRADYCARDIA BELOW 30 BPM. THE VENTRICULAR THRESHOLD WAS 5.5 V, 0.8 MS AND IMPEDANCE 2 30 OHMS BIPOLAR, 180 OHMS UNIPOLAR. A CHEST X-RAY REVEALED RIGHT VENTRICULAR LEAD DISLODGEMENT. WHEN OPENING THE POCKET ALL PACING WAS LOST. THE LEAD WAS REMOVED AND REPLACED. NO ADDITIONAL COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1788TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention (B)(4)