BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2163421 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07212
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 26, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN ADDITIONAL INFORMATION IS RECEIVED, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS NO RETURN OF PRODUCT IS INTENDED, THEREFORE THIS CLINICAL ALLEGATION CANNOT BE CONFIRMED OR DENIED. NO FURTHER INFORMATION IS EXPECTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED NOISE AND OVERSENSING. AS THE PATIENT HAD RECEIVED INAPPROPRIATE SHOCK THERAPY, IT WAS THOUGHT THIS WAS DUE TO A LEAD FRACTURE. IMPEDANCE MEASUREMENTS HAVE INCREASED SINCE IMPLANT, BUT REMAIN WITHIN ACCEPTABLE RANGE. SHOCK IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS. NOISE WAS ONLY NOTED ON THE VENTRICULAR AND NOT THE SHOCK CHANNEL. ISOMETRIC MANEUVERS REPRODUCED THE NOISE. THE PATIENT WITH THIS LEAD IS NOT PACEMAKER DEPENDANT. A REVISION TO IMPLANT ANOTHER PACE/SENSE LEAD IS INTENDED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A REVISION PROCEDURE WAS PERFORMED. AN ADDITIONAL PACE/SENSE RIGHT VENTRICULAR LEAD WAS IMPLANTED. THE PACE/SENSE PORTION OF THIS LEAD WAS SURGICALLY CAPPED AND ABANDONED. DEFIBRILLATION TESTING WAS PERFORMED SUCCESSFULLY. THE VENTRICULAR TACHYCARDIA WAS CONVERTED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Other