BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 4974438 · Received August 5, 2015

    Report

    Report Number
    2017865-2015-27471
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 16, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR PACE/SENSE LEAD EXHIBITED OVERSENSING. THE PATIENT HAD TWO VENTRICULAR FIBRILLATION DETECTIONS WITH ABORTED SHOCKS DUE TO NOISE. THE PATIENT WAS ASYMPTOMATIC. THE LEAD WAS CAPPED AND REPLACED AND THE PATIENT WAS FINE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514742 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1688TC/52 0002112916

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention