BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910860 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15548
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    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 LEAD DISPLAYED POOR SENSING AND LOSS OF CAPTURE AT A ROUTINE FOLLOW UP. A LEAD DISLODGEMENT WAS SUSPECTED AS THE ROOT CAUSE OF THE ISSUE. A PROCEDURE WAS PERFORMED TO ASSESS THE LEAD ISSUE, AND AFTER SOME DIFFICULTY REPOSITIONING THE LEAD, THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE LEAD SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OTHER THAN THE ADDITIONAL PROCEDURE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17430 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R