BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2153480 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06755
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. 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 THE LATITUDE SYSTEM DETECTED A RIGHT VENTRICULAR (RV) IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS. THE DEVICE WAS INTERROGATED AND THE LEAD IMPEDANCE WAS NOTED. THE RV LEAD WAS REPORTEDLY FRACTURED. AN INVASIVE REVISION PROCEDURE WAS PERFORMED. THE RV LEAD WAS SUCCESSFULLY EXTRACTED AND REPLACED. THE DEVICE WAS ELECTIVELY EXPLANTED AND REPLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R 4542| 0158| 4470| H220| A135| 4548