BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211616 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09386
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 6, 2013
    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

    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 DURING A HEMATOMA EVACUATION PROCEDURE, IT WS IDENTIFIED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED. THE RV LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE LEAD WAS EXPLANTED LATER FOR AN UNRELATED REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311847 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R 4592| N140| 4549| 4470| 0296| 0185| N119