BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3092544 · Received May 3, 2013

    Report

    Report Number
    2124215-2013-02915
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 WAS REPOSITIONED DUE TO DISLODGMENT INTO THE ATRIUM. THIS WAS DISCOVERED BY THE PATIENT AND VERIFIED BY AN X-RAY. LEADS WERE CHECKED AND TACHYCARDIA THERAPY WAS TURNED OFF BY THE PHYSICIAN. THE LEAD WAS APICALLY POSITIONED; DISTAL FROM THE PREVIOUS IMPLANT POSITION WHICH WAS NEAR THE BRADYCARDIA LEAD WAS EXPLANTED. THIS LEAD IS NOT EXPECTED TO BE RETURNED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194862 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R N140| 1688TC| 0296| 4543| K063