BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL DX

    MDR report key: 5142547 · Received October 10, 2015

    Report

    Report Number
    2017865-2015-29189
    Event Type
    Injury
    Date Received
    October 10, 2015
    Date of Event
    August 26, 2015
    Report Date
    September 5, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 OVERSENSING. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674108 TENDRIL DX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1388T/46 0002344745

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention