BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913759 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00148
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 (RV) LEAD EXHIBITED LOSS OF CAPTURE AT MAXIMUM OUTPUTS DURING AN IN-CLINIC EVALUATION. A CHEST X-RAY AND ECHOCARDIOGRAM WAS PERFORMED REVEALING THAT THE LEAD HAD PERFORATED THROUGH THE ENDOCARDIUM AND OUT OF THE RV APEX. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THIS PRODUCT WAS SUCCESSFULLY REPOSITIONED INTO THE RV APEX. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20505 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R N140| 1290| 5568| 4542| 0295| 4457