BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL DX

    MDR report key: 3926246 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15549
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    April 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED NOISE, LOSS OF CAPTURE AND LOW IMPEDANCE. THE PATIENT EXPERIENCED NEAR SYNCOPE ISSUES. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WOULD BE FOLLOWED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404208 TENDRIL DX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1388T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention