BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 4231316 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18098
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 26, 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
    NY, US
    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 AN INSULATION ANOMALY WAS OBSERVED ON THE ATRIAL LEAD. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715531 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1788TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention