BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1861146 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15558
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED, DURING WHICH, THE DEVICE WAS EXPLANTED AND REPLACED. THE RV LEAD WAS LEFT IN SERVICE WITH THE NEW DEVICE. AN ATTEMPT HAS BEEN MADE TO GATHER ADDITIONAL INFORMATION ABOUT THIS EVENT, AND TO HAVE THE EXPLANTED DEVICE RETURNED FOR ANALYSIS. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS LATER RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS. AN INITIAL VISUAL INSPECTION OF THE DEVICE FOUND NO ANOMALIES. ALL SET SCREWS WERE CONFIRMED TO BE OPERATING NORMALLY. A REVIEW OF DEVICE MEMORY CONFIRMED THE OUT OF RANGE IMPEDANCE MEASUREMENTS. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF DIAGNOSTIC TESTS THAT VERIFIED NORMAL PACING, SENSING AND SHOCKING FUNCTIONS. FINAL ANALYSIS CONCLUDED THAT THIS DEVICE WAS OPERATING WITHIN SPECIFICATION. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A HIGH PACING IMPEDANCE MEASUREMENT WAS DETECTED ON THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RESULTING IN A LATITUDE RED ALERT. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS OBSERVATION. CONCERN WAS EXPRESSED OVER A POSSIBLE LOOSE RV SET SCREW.

    Description of Event or Problem · 1

    --

    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 73 YR Life Threatening| R 4054| 4591| 0185| H220| 4542