BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2052764 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03887
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 IMPLANTABLE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING LOSS OF CAPTURE AND HAD DISLODGED. A REVISION PROCEDURE TOOK PLACE AND IT WAS PARTIALLY ABANDONED. A NEW PACE/SENSE RV LEAD WAS SUCCESSFULLY IMPLANTED. HOWEVER, THE LEAD REMAINS IN SERVICE FOR DEFIBRILLATION. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R 4135| 4554| 0184| H227| 4136| MISMATCH