BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4231393 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18190
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    August 15, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, LOW SENSING VALUES WERE OBSERVED. AFTER MULTIPLE ATTEMPTS, THE LEADS HELIX HAD BECOME CLOGGED WITH TISSUE. THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715727 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1