BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 4893531 · Received July 6, 2015

    Report

    Report Number
    2017865-2015-26680
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 4, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED HIGH LEAD IMPEDANCE. THE LEAD WAS PROGRAMMED OFF. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434707 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1688TC/40 3491302

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR