BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052525 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05518
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 ONE DAY POST IMPLANT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. A REVISION PROCEDURE WAS PERFORMED WHERE IT WAS NOTED THAT THE DISTAL PORTION OF THE LEAD WAS REINSERTED INTO THE HEADER OF THE DEVICE AND THE SET SCREW WAS TIGHTENED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AND THE DEVICE AND LEAD REMAIN IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156338 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R T127| 0185| 1488T| 4548| N051| 4087