BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170016 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09788
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 27, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS ACTIVELY IMPLANTED. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS EXPLANTED SECONDARY TO THE LEFT VENTRICULAR LEAD REPLACEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD BECAME DISLODGED. THE DEVICE WAS CHECKED FOLLOWING A SLOW VENTRICULAR TACHYCARDIA IN WHICH THE PATIENT CONVERTED ON THEIR OWN. THE RV THRESHOLDS WERE FOUND TO BE SUBSTANTIALLY HIGHER THAN AT IMPLANT. A REVISION PROCEDURE TOOK PLACE AND THE LEAD WAS SUCCESSFULLY REPOSITIONED. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R 4543| 0185| N119| 4470