BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT LOW VOLTAGE LEAD

    MDR report key: 13620681 · Received February 28, 2022

    Report

    Report Number
    2017865-2022-04211
    Event Type
    Injury
    Date Received
    February 28, 2022
    Report Date
    February 28, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HEART RHYTHM SOCIETY TITLE: ELECTRICAL ABNORMALITIES WITH ST. JUDE/ABBOTT PACING LEADS: A SYSTEMATIC REVIEW AND META-ANALYSIS (HEART RHYTHM 2021;18:2061¿2069. DOI:10.1016/J.HRTHM.2021.08.026). AUTHORS: ROSHNI V. KHATIWALA, MD; ELIZABETH MULLINS, MD; DALI FAN, MD; UMA N. SRIVATSA, MD, MS, FHRS; SANKET S. DHRUVA, MD, MHS; ADAM OESTERLE, MD LOW IMPEDANCE A072202, PACING PROBLEM A0712.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ABBOT PACING LEADS WERE USED AS PART OF A STUDY INVOLVING ABBOTT AND NON ABBOTT LEADS. THIS EVENT IS TO REPORT THE OBSERVATIONS ON THE ABBOTT LEADS USED IN THE STUDY. THE STUDY MEASURED THE RATE AT WHICH ABBOTT LEADS DEMONSTRATED ABNORMALITIES ACROSS 8 PREVIOUS STUDIES. THE ABNORMALITIES TRENDED IN THE STUDY INCLUDED LEAD NOISE, ABRUPT CHANGES IN IMPEDANCE (BOTH HIGH AND LOW), LEAD FRACTURES, INSULATION BREAKS, DECREASES IN SENSING INCLUDING A FAILURE TO SENSE, HIGH CAPTURE THRESHOLDS INCLUDING LOSS OF CAPTURE, INAPPROPRIATE PACING INHIBITION, AND INAPPROPRIATE MODE SWITCHES. ABBOTT PACING LEADS WERE FOUND TO HAVE A 6.1% ABNORMALITY RATE. THE STUDY ALSO REPORTED ON RESOLUTIONS TO THE ABNORMALITIES INCLUDING PROGRAMMING CHANGES AND SURGERY INVOLVING EITHER LEAD REVISION OR EXPLANT. THE STUDY FOUND THAT WHILE EITHER OBSERVATION OR PROGRAMMING CHANGES WERE USUALLY SUFFICIENT, IN 1.0% OF CASES LEAD REVISION OR EXTRACTION WAS PERFORMED. THE STUDY CONCLUDED THAT ABBOTT LEADS ARE ASSOCIATED WITH AN INCREASED RATE OF ABNORMALITIES AND INCREASED RATE OF LEAD REPROGRAMMING AND LEAD REVISION OR EXTRACTION OVER OTHER MANUFACTURERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883179 ABBOTT LOW VOLTAGE LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LOW VOLTAGE LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention