BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2052019 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03992
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 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

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS TRANSVENOUS DEFIBRILLATION LEAD WAS HOSPITALIZED AFTER EXPERIENCING SYNCOPE. IT WAS NOTED THAT THIS PATIENT HAD A 12 SECOND PAUSE IN PACING. PATIENT ISOMETRICS AND MANIPULATIONS WERE PERFORMED, AND THE LOSS OF CAPTURE COULD NOT BE RECREATED. IT WAS FURTHER NOTED THAT WHEN THE LEFT VENTRICULAR (LV) LEAD WAS PROGRAMMED OFF, GOOD RV PACING AND CAPTURE WERE OBSERVED. THERE WAS ALSO A HISTORY OF NOISE ON THE SHOCK CHANNEL. ALL OTHER LEAD MEASUREMENTS WERE NOTED TO BE NORMAL. TECHNICAL SERVICES (TS) DISCUSSED THE POSSIBILITY OF THE TWO INSTANCES OF PREVIOUS NOISE COULD HAVE BEEN DUE TO THE MECHANICAL INTERACTION OF A TEMPORARY PACING WIRE WHILE THE PATIENT WAS HOSPITALIZED. TS ALSO DISCUSSED THAT IT WAS UNKNOWN AT THIS TIME WHAT CAUSED THE REPORTED ASYSTOLE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE RIGHT VENTRICULAR (RV) SENSITIVITY WAS DECREASED TO LEAST TO AVOID OVERSENSING OF ATRIAL ACTIVITY. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening 1861| 4543| 4549| 0148| 4017| T127| H210