BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3963601 · Received July 29, 2014

    Report

    Report Number
    2124215-2014-14600
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN EVALUATION WAS PERFORMED. A VISUAL INSPECTION INDICATES THAT THE LEAD BODY WAS TWISTED AND THE HELIX WAS RETRACTED. THE ALLEGATION AGAINST THE OBSERVATION COULD NOT BE CONFIRMED BY ANALYSIS. FURTHER, THE LEAD PASSED ELECTRICAL TESTING. THE LEAD WAS CLINICALLY OUT OF SPECIFICATION AND THE DAMAGE WAS INDUCED IN THE FIELD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND AN ATTEMPTED RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE GREATER THAN 2,000 OHMS DURING IMPLANT PROCEDURE PRIOR TO WOUND CLOSURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE LEAD WAS NEVER IN SERVICE WHILE THE ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441581 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 0296| E160