BEUDAMED
    FDA Adverse Event Death Summary report: N

    BI,EXT/RET SCREW-IN,IS1 1 LEAD

    MDR report key: 12071773 · Received June 25, 2021

    Report

    Report Number
    2017865-2021-24140
    Event Type
    Death
    Date Received
    June 25, 2021
    Date of Event
    April 10, 2000
    Report Date
    June 25, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    K925347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI NOT AVAILABLE AS PRODUCT WAS MANUFACTURED ON OR BEFORE SEP 23, 2014. A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 28.7 CM WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-24139, 2017865-2021-24141.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963980 BI,EXT/RET SCREW-IN,IS1 1 LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1148T/58

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death ENDOCARDIAL| SYNCHRONY III