BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 11843311 · Received May 18, 2021

    Report

    Report Number
    2017865-2021-18386
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    April 29, 2021
    Report Date
    June 16, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502887
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD EVENT OF NOISE WAS CONFIRMED. AS RECEIVED, A COMPLETE LEAD WAS RETURNED IN ONE PIECE. FINAL ANALYSIS FOUND AN EXTERNAL INSULATION ABRASION BREACHING THE OUTER INSULATION AT 17.6 CM TO 18.4 CM FROM THE CONNECTOR PIN. THE DAMAGE WAS CONSISTENT WITH FRICTION TO DEVICE CAN. NO SHORTS WERE FOUND.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-18387. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS OBSERVED THAT BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS EXHIBITED NOISE. THE LEADS WERE EXPLANTED AND REPLACED, AND THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738404 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 2898716 05414734502887

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention TENDRIL STS| TENDRIL STS