BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3904871 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09202
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 18, 2014
    Report Date
    June 20, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE DEFIBRILLATION LEAD PRESENTED TO THE HOSPITAL FOLLOWING A SYNCOPAL EPISODE. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND REVEALED A LEAD PERFORATION AND CARDIAC TAMPONADE/PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND AN ECHOCARDIOGRAM CONFIRMED SUCCESSFUL DRAINAGE OF THE FLUID. THE LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT LATER PRESENTED TO THE HOSPITAL WITH COMPLAINT OF PAIN AND SHORTNESS OF BREATH (SOB) AND WAS OBSERVED TO HAVE RETURN OF PERICARDITIS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS RELEASED THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384986 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R 4470| 4554| N160| 0292