BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 9717089 · Received February 17, 2020

    Report

    Report Number
    2017865-2020-02126
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Report Date
    February 17, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: INVESTIGATION OF POTENTIAL PACING LEAD FAILURE: AN AUSTRALIAN SINGLE-CENTRE ELSEVIER: 2019 VOLUME 28, SUPPLEMENT 4, PAGE S217 AUTHORS: R. SAMUEL, L. SEGAN, M. PERRIN ST VINCENT¿S HEALTH, FITZROY, AUSTRALIA & BARWON HEALTH, GEELONG, AUSTRALIA. NOTE: THE IDENTITY OF THE PATIENTS UNDER STUDY AS WELL AS THE INDIVIDUAL SERIAL NUMBERS INVOLVED IN THE STUDY ARE UNKNOWN. IT IS POSSIBLE THESE ISSUES MAY HAVE BEEN ALREADY INDIVIDUALLY REPORTED BUT THE INFORMATION CAN'T BE VERIFIED DUE TO THE ANONYMITY OF PARTICIPANTS IN SUCH STUDIES.

    Description of Event or Problem · 1

    THIS IS EVENT IS TO REPORT FINDINGS OF A CLINICAL REVIEW ARTICLE INVESTIGATING POTENTIAL LEAD FAILURE IN ABBOTT /ST JUDE MEDICAL ST JUDE TENDRIL 2088 LEADS. DATA FROM A RETROSPECTIVE COHORT OF PATIENTS WITH ST JUDE TENDRIL 2088 LEADS IMPLANTED FROM 2010 WAS COLLECTED THROUGH A DATABASE. LEADS WERE ELIGIBLE IF THEY HAD AT LEAST ONE DEVICE CHECK PERFORMED AT THE ONE MONTH MARK POST IMPLANTATION. A CLINICAL REVIEW OF EACH PACEMAKER CHECK WAS PERFORMED TO ASSESS FOR THE PRESENCE OF ¿NOISE¿, THE MOST COMMON MANIFESTATION OF LEAD FAILURE IN THESE DEVICES. A TOTAL OF 408 LEADS WERE ELIGIBLE FOR INCLUSION IN THE STUDY. MEDIAN FOLLOW UP WAS 2.2 YEARS. THERE WERE 10 CASES OF LEAD NOISE SUGGESTIVE OF LEAD FAILURE, A FAILURE RATE OF 2.45%. 81 LEADS WERE FOLLOWED UP FOR AT LEAST 4 YEARS, OF WHICH 5 HAD FAILED AFTER THIS TIME POINT, A FAILURE RATE OF 6.17%. THE RATE OF TENDRIL 2088 LEAD FAILURE APPEARS LOWER THAN THAT SUGGESTED BY OTHER RETROSPECTIVE STUDIES PERFORMED OVERSEAS. FURTHER RESEARCH IS REQUIRED IN THE LONGER TERM TO ASSESS FAILURE RATE BEYOND 5¿10 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179969 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088

    Patients

    Seq Age Sex Outcome Treatment
    1