BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR ICD, US

    MDR report key: 20248684 · Received September 18, 2024

    Report

    Report Number
    2017865-2024-65256
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWS
    UDI-DI
    05414734507530
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL INFORMATION WAS OBTAINED FROM THE ARTICLE TITLED "BRADYCARDIA-DEPENDENT CONDUCTION BLOCK OF THE ATRIAL TISSUE IN A PATIENT AFTER DOUBLE-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTATION. JOURNAL OF ELECTROCARDIOLOGY 86 (2024) 153776. HTTPS://DOI.ORG/10.1016/J.JELECTROCARD.2024.153776.¿ AUTHORS: KAILUN ZHU, ZHANXIONG ZHENG, YANXI SHI, JIANJIANG XU, ZHENLIANG CHU A, D. DEPARTMENT OF CARDIOLOGY, THE SECOND AFFILIATED HOSPITAL OF JIAXING UNIVERSITY, JIAXING, ZHEJIANG 314000, CHINA B MEDICAL COLLEGE OF YANGZHOU UNIVERSITY, YANGZHOU, JIANGSU 225009, CHINA C DEPARTMENT OF CARDIOLOGY, JIANGSU TAIZHOU PEOPLE¿S HOSPITAL, TAIZHOU, JIANGSU 225300, CHINA D DEPARTMENT OF CARDIOLOGY, THE FIRST AFFILIATED HOSPITAL OF DALIAN MEDICAL UNIVERSITY, DALIAN, LIAONING 116000, CHINA.

    Description of Event or Problem · 0

    INFORMATION ORIGINATING FROM PEER REVIEW ARTICLE: IT WAS REPORTED THAT PARTIAL ATRIAL LOSS OF CAPTURE, HIGH CAPTURE THRESHOLD AND PSEUDO-ATRIAL FUSION WAS OBSERVED POST IMPLANT WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD POST IMPLANT. PROGRAMMING CHANGES WERE MADE. THE ICD AND RA LEAD REMAINED IMPLANTED AND IN USE FOLLOWING THE PROGRAMMING CHANGES. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359819 ELLIPSE DR ICD, US Implantable cardioverter defibrillator (non-CRT) LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2377-36Q A000110977 05414734507530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TENDRIL STS