BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2161604 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-09794
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATIONS INDICATED THIS LEAD WAS RETURNED SEVERED. THERE WERE SETSCREW MARKS NOTED ON ALL TERMINAL CONNECTORS, THE EXTRACTING STYLET REMAINED INSIDE OF THE DISTAL SEGMENT, AND WAS STRETCHED AND TWISTED AT THE PROXIMAL END OF THE PROXIMAL SHOCKING COIL. CALCIUM DEPOSITS WERE NOTED OVER MOST OF THE SCREEN MESH. THE DIRCET CURRENT RESISTANCE TEST REVEALED THAT THE RETURNED SEGMENTS OF THIS LEAD WERE CONTINUOUS. THE INCREASE IN LEAD IMPEDANCE COULD HAVE BEEN THE RESULT OF THE CALCIUM DEPOSITS OVER THE LEAD TIP. INITIAL ALLEGATION NOT CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING A REVISION PROCEDURE, IT WAS OBSERVED THIS RIGHT VENTRICULAR (RV) LEAD HAD HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. A FLUOROSCOPIC REVISION WAS PERFORMED, AND NO ANOMALIES WERE NOTED. THE DEVICE WAS DISCONNECTED, AND MEASUREMENTS WERE TAKEN WITH THE PACING SYSTEM ANALYZER (PSA), WHICH ALSO REVEALED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS, INCREASED THRESHOLD MEASUREMENTS AND POOR MORPHOLOGY. THE DECISION WAS MADE TO EXPLANT THE RV LEAD, AND IMPLANT A NEW LEAD. ALL MEASUREMENTS WERE THEN WITHIN RANGE. A DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED, AND INDUCED ARRHYTHMIA'S WERE CONVERTED BACK TO SINUS RHYTHM. THE NEW SYSTEM WAS IMPLANTED SUBMUSCULAR INSTEAD OF SUBCUTANEOUSLY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED, AND NO ALLEGATIONS AGAINST THE BOSTON SCIENTIFIC PRODUCT.

    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