BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151468 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06016
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THIS LEAD REMAINS IN SERVICE. 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 THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS. THE PATIENT WAS EXPERIENCING INTERCOSTAL MUSCLE CONTRACTIONS AND A CHEST X-RAY REVEALED A POSSIBLE PERFORATION OF THE PERICARDIUM. AN INVASIVE PROCEDURE WAS PERFORMED AND THIS LEAD WAS REPOSITIONED IN THE RIGHT VENTRICULAR APEX. THERE WAS NO EVIDENCE OF A PERICARDIAL EFFUSION AND A PERFORATION WAS NOT VISUALLY CONFIRMED. ALL LEAD DIAGNOSTICS FOLLOWING THE PROCEDURE WERE ACCEPTABLE.

    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 68 YR Required Intervention 4135| 0180| E110