BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1871672 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-19705
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, VISUAL INSPECTION OF A COMPLETE LEAD IDENTIFIED SET SCREW MARKS ON ALL TERMINALS. THE IS-1 PROXIMAL SEAL RING WAS LIFTED. THE TERMINAL INSULATION WAS ROLLED BACK AND STUCK TO ITSELF. THERE WERE SOME TEARS IN THE TERMINAL INSULATION ON THE PROXIMAL SEAL RINGS, IN THE AREA WHERE THE INSULATION HAD ROLLED BACK. FURTHER INSPECTION OF THE LEAD REVEALED A SEPARATION OF THE GORE COVERING FROM THE MEDICAL ADHESIVE (MA) AT THE PROXIMAL EDGE OF THE PROXIMAL SHOCKING COIL. ASSOCIATED WITH THIS WAS A SLIGHT STRETCHING OF THE PROXIMAL END OF THIS SHOCKING COIL. TWO ABRASIONS (590-597MM AND 617-619MM FROM THE TERMINAL PIN) ON THE LEAD BODY WERE IDENTIFIED. THE LEAD WAS PUT THROUGH AND PASSED TESTS THAT VERIFIED THE INSULATION INTEGRITY AND ELECTRICAL CONTINUITY OF THE LEAD. THE CLINICAL OBSERVATION OF NO CAPTURE COULD NOT BE CONFIRMED THROUGH LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS EXPLANTED DUE TO NO CAPTURE. THERE WERE NO ADVERSE EVENTS REPORTED. THE LEAD WAS RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS.

    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 86 YR Hospitalization| L| R N119| 7121| 5076| 0185| H210| 4543