BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 3923281 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14576
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 19, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND AN INSULATION ABRASION EXPOSING THE OUTER COIL AT 18.0 CM TO 19.5 CM FROM THE CONNECTOR PIN. THE ABRASION WAS CONSISTENT WITH CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402047 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention