BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 19981707 · Received August 14, 2024

    Report

    Report Number
    2017865-2024-62624
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HTTPS://EMDR.FDA.GOV/EMDR/FORMREDACTION/B5.JSF#.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE ATRIAL LEAD EXHIBITED OVERSENSING DUE TO NOISE THAT RESULTED IN INAPPROPRIATE MODE SWITCH. INSULATION BREACH WAS SUSPECTED BUT NOT CONFIRMED. THE LEAD WILL CONTINUE TO BE MONITORED. THE PATIENT WAS STABLE AND ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263981 TENDRIL ST No Match NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1888TC/52 3562554

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female ASSURITY| TENDRIL