BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C

    MDR report key: 4888910 · Received July 2, 2015

    Report

    Report Number
    2124215-2015-05405
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    January 29, 1996
    Report Date
    August 27, 2020
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL REPORT WAS ORIGINALLY SUBMITTED ON 4/15/1996 WITH OLD NUMBERING STYLE OF #9610 LWS. THIS REPLACEMENT MDR IS TO LINK THE SUPPLEMENTAL REPORT SENT ON MDR #2124215-2015-05405. UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE RETURNED PROXIMAL SEGMENT WAS PERFORMED. VISUAL INSPECTION NOTED DAMAGE TO THE LEAD INSULATION. DETAILED ANALYSIS CONFIRMED THE ELECTRICAL CONTINUITY OF THE LEAD SEGMENT. FINAL EVALUATION DETERMINED THAT DUE TO THE LOCATION AND TYPE OF DAMAGE THIS WAS LIKELY CAUSED BY LEAD-ON-LEAD CONTACT COUPLED WITH MOVEMENT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE RE-EVALUATED IF ADDITIONAL DETAILS ARE RECEIVED

    Description of Event or Problem · 1

    THIS INITIAL REPORT WAS ORIGINALLY SUBMITTED ON 4/15/1996 WITH OLD NUMBERING STYLE OF #9610 LWS. THIS REPLACEMENT MDR IS TO LINK THE SUPPLEMENTAL REPORT SENT ON MDR #2124215-2015-05405. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND A TRANSVENOUS DEFIBRILLATION LEAD EXPERIENCED INAPPROPRIATE THERAPY. AN INVASIVE ANALYSIS WAS PERFORMED AND THE PROBLEM WAS SUSPECTED TO BE ASSOCIATED WITH THE RATE SENSING PORTION OF THE TRANSVENOUS DEFIBRILLATION LEAD, SO IT WAS CAPPED. A NEW RATE SENSING LEAD WAS IMPLANTED. THE HIGH VOLTAGE PORTION OF THE LEAD REMAINS ACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433279 ENDOTAK C IMPLANTABLE LEAD NVY BOSTON SCIENTIFIC 0062

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Life Threatening| H| R