BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2040888 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00978
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    November 24, 2010
    Report Date
    January 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. THE PRELIMINARY DIAGNOSIS WAS OF CHEST PAIN SECONDARY TO PERICARDITIS. PAIN MEDICATIONS WERE ADMINISTERED TO THE PATIENT AND A CT ANGIOGRAM SHOWED EVIDENCE OF A MODERATE SIZED PERICARDIAL EFFUSION WHICH MAY HAVE OCCURRED DURING PLACEMENT OF THIS RIGHT VENTRICULAR LEAD. OBSERVATION OF THE PATIENT CONTINUED AND AN ECHOCARDIOGRAM SHOWED A SMALL POSTERIOR PERICARDIAL SPACE EFFUSION WITHOUT HEMODYNAMIC CONSEQUENCES. THE PATIENT WAS DISCHARGED WHEN SHE WAS NO LONGER SYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR MISMATCH| 0180| 4554| N119