BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 3923220 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14534
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 12, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND LEAD ABRASION CONSISTENT WITH FRICTION AGAINST ANOTHER DEVICE AT 33.4 TO 34.2CM FROM THE CONNECTOR PIN, EXPOSING THE OUTER COIL. THIS DAMAGE COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT SEEN IN THE FIELD.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC WAS SEEN IN CLINIC FOR A ROUTINE FOLLOW-UP. THE ATRIAL LEAD EXHIBITED NOISE. THE LEAD REMAINED IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTED THAT A HIGH PACING THRESHOLD WAS OBSERVED ON THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401612 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1788TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention (B)(4)