BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2163310 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07977
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THIS RIGHT VENTRICULAR DEFIBRILLATION (RV) LEAD EXHIBITED LOSS OF CAPTURE AND A CHANGE IN IMPEDANCE MEASUREMENTS. LATER, THE PATIENT FELT DIAPHRAGMATIC STIMULATION, AND ADDITIONAL INVESTIGATION WAS DONE BY THE PHYSICIAN THAT REVEALED THIS RV LEAD DISLODGED AND PERFORATED THE RIGHT VENTRICULAR WALL. THE PATIENT UNDERWENT SURGERY TO SOLVE THE PERFORATION, AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS DEACTIVATED. A NEW SYSTEM IS SCHEDULED TO BE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE 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 Life Threatening| R