BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2162519 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07584
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    September 2, 2009
    Report Date
    April 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION REGARDING AN INQUIRY OF STORED NON SUSTAINED VENTRICULAR TACHYCARDIA EPISODES FROM A LATITUDE REPORT. A REVIEW OF THE DATA BY TECHNICAL SERVICES NOTED THAT THE SIGNAL ON THE ELECTROCARDIOGRAMS IS SHARP, AND NON PHYSIOLOGIC SUGGESTING METAL TO METAL CONTACT. IT WAS ALSO NOTED THAT A CHANGE IN LEAD IMPEDANCES, SENSING, AND AN INCREASE IN THRESHOLDS ON THE RIGHT VENTRICULAR LEAD (0185) WAS RECORDED. ADDITIONAL INFORMATION PROVIDED NOTED A REPLACEMENT PROCEDURE TOOK PLACE IN 2009, TO REPLACE A DEVICE DUE TO NORMAL BATTERY DEPLETION. A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED WITH THE OLD RIGHT VENTRICULAR (RV) (B)(4). AT A FOLLOW UP OF THE DEVICE AND LEAD OUT OF RANGE PACING IMPEDANCES WERE REVEALED. SUBSEQUENTLY, THE PHYSICIAN ELECTED TO REPLACE THE EXISTING RV LEAD AND IMPLANT A NEW RIGHT VENTRICULAR LEAD (B)(4). THE OLD RIGHT VENTRICULAR LEAD (0145) REMAINED IN THE PATIENT, AND WAS NEVER EXPLANTED. THE DEVICE WAS REPROGRAMMED AND AN X-RAY REVEALED THAT THE (0145) RIGHT VENTRICULAR LEAD HAD STRETCHED COILS AFTER THE REPLACEMENT PROCEDURE. AT THIS TIME NO ADDITIONAL INFORMATION IS AVAILABLE AND THE SYSTEM REMAINS IMPLANTED. NO FURTHER ADVERSE PATIENT EFFECT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0145

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 0145| 1850