BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3061809 · Received April 16, 2013

    Report

    Report Number
    2124215-2013-06227
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED SEVERED IN TWO SEGMENTS. A SEGMENT OF THE LEAD AND/OR INSULATION APPEARED TO BE MISSING FROM THE MID-BODY SECTION OF THE LEAD. THE EXTRACTING STYLET WAS ALSO RETURNED INSIDE THE THE TIP SEGMENT OF THE LEAD. THE PROXIMAL END OF THE DISTAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION. TISSUE AND BODY FLUIDS WERE ALSO NOTED ON THE DISTAL END OF THE CONDUCTOR COILD AND ENTWINED IN THE TIP. CUTS WERE NOTED IN THE LEAD INSULATION AND LASER EXTRACTION DAMAGE TO THE INSULATION WAS ALSO OBSERVED. RESISTANCE TESTING WAS THEN COMPLETED TO ASSESS THE LEAD'S ELECTRICAL INTERGRITY. MEASUREMENTS WERE WITHIN NORMAL LIMITS. X-RAY IMAGES WERE TAKEN AND NO ANOMALIES WERE FOUND. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORT OBSERVATIONS OF THE LEAD SEGMENTS RETURNED. THE DAMAGE SUSTAINED TO THE LEAD WAS CONFIRMED TO BE PROCEDURELY INDUCED.

    Additional Manufacturer Narrative · 1

    THE RV LEAD WAS RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOLLOWING THIS SUB-PECTORAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT PROCEDURE, NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) CHANNEL WHICH WAS BEING OVERSENSED. DAILY MEASUREMENTS WERE SHOWING SOME OUT OF RANGE RV IMPEDANCE MEASUREMENTS, GREATER THAN 2,000 OHMS. A REVISION WAS PERFORMED WHERE ADDITIONAL TESTING WAS PERFORMED TO CONFIRM PROPER CONNECTION. TESTS CONFIRMED THE LEAD WAS FULLY INSERTED PROPERLY, NOISE COULD NOT BE RECREATED WITH LEAD MANIPULATION, HEADER WAS TIGHT, PULL TEST DID NOT REVEAL LOOSE CONNECTION, IMPEDANCE TESTING CONFIRMED NORMAL MEASUREMENTS THROUGH DEVICE AND SETSCREWS WERE TIGHT. THE PHYSICIAN ALSO TRIED REINSERTING THE LEAD IN THE HEADER AS WELL AS TESTING THE LEAD THROUGH THE PACING SYSTEM ANALYZER (PSA) AND NORMAL MEASUREMENTS WERE CONFIRMED. SINCE THE ISSUE COULD NOT BE CONFIRMED WITH EITHER THE DEVICE OR THE RV LEAD, BOTH PRODUCTS WERE REMOVED AND RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162643 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R N119| 4136| 4543| 0293| N140| 0181