BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2050511 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04210
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WAS THOROUGHLY TESTED. VISUAL INSPECTION NOTED THREE CUTS IN THE INSULATION, WHICH MOST LIKELY OCCURRED DURING THE EXPLANT PROCEDURE. THE REPORTED ELECTRICAL ISSUE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD EXHIBITED THRESHOLD MEASUREMENTS GREATER THAN 5V AT 2MS. THE PHYSICIAN FELT THE LEAD WAS IN A GOOD POSITION, SO HE DID NOT WANT TO REPOSITION IT. A PROCEDURE WAS DONE TO EXPLANT AND REPLACE THE LEAD. A NEW LEAD OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED. THIS LEAD WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention N119| 0157| 4554| 1788TC