BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 4870023 · Received June 25, 2015

    Report

    Report Number
    2017865-2015-07954
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 26, 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 LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411944 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1688TC/58 P000000705

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention