BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780612 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12716
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE FOR A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WHEN THE RIGHT VENTRICULAR (RV) LEAD WAS PLACED A PERFORATION OCCURRED. THE PATIENT'S BLOOD PRESSURE DROPPED AND THE PHYSICIAN REPOSITIONED THE RV LEAD, THEN PLACED BOTH THE RIGHT ATRIAL (RA) LEAD AND LEFT VENTRICULAR (LV) LEADS. AFTER IMPLANTING THE OTHER LEADS, THE PATIENTS BLOOD PRESSURE INCREASED TO 88 SYSTOLIC, SO IT IS UNKNOWN IF THERE WAS ANY CARDIAC TAMPONADE. AFTERWARDS THE PHYSICIAN PERFORMED A PERICARDIAL THORACENTESIS. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT AND WAS STABLE. THE PATIENT WAS CHECKED AGAIN THE FOLLOWING DAY, AND THEY WERE STABLE AND ALL VITALS WERE NORMAL. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R 4135| 0295