BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 17447421 · Received August 2, 2023

    Report

    Report Number
    2124215-2023-41147
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    January 1, 2002
    Report Date
    August 2, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    J. LIU, G. BRUMBERG, R. RATTAN, ET AL., LONGITUDINAL FOLLOW-UP OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS, AM. J. CARDIOL. 113 (1) (2014) 103-106. HTTP://DX.DOI.ORG/10.1016/J.AMJCARD.2013.08.046.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA ARTICLE OF INTEREST LITERATURE REVIEW THAT THE AUTHORS INVESTIGATED THE OVERALL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD SURVIVAL RATE OF LEAD MODELS FROM THREE MAJOR MANUFACTURERS IMPLANTED AT THE HOSPITALS OF THE UNIVERSITY OF PITTSBURGH MEDICAL CENTER. ALL PATIENTS RECEIVING A MEDTRONIC, BOSTON SCIENTIFIC, OR ST. JUDE MEDICAL TRANSVENOUS ICD LEAD AT THE UNIVERSITY OF PITTSBURGH MEDICAL CENTER FROM NOVEMBER 2000 TO MARCH 2012 WERE INCLUDED. A TOTAL OF 5,288 PATIENTS, INCLUDING 2,190 RELIANCE (MODELS 0185 AND 0158) (BOSTON SCIENTIFIC, NATICK, MASSACHUSETTS), WERE INVOLVED. FUNCTIONAL LEADS THAT WERE REPLACED INCLUDED SIXTY-TWO RELIANCE. LEADS REPLACED FOR ELECTRICAL FAILURE INCLUDED TWENTY-SIX RELIANCE. OF THE TWENTY-SIX RELIANCE LEADS, THIRTEEN EXHIBITED SENSING/NOISE FAILURE, SIX EXHIBITED HIGH THRESHOLDS, FOUR EXHIBITED PERFORATION/DISLODGEMENTS, THREE EXHIBITED HIGH-VOLTAGE FAILURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285260 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male