BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 4191819 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05457
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    January 3, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THE REPORTED FIELD EVENT OF NOISE WAS CONFIRMED. THE DEVICE WAS TESTED ON THE HI POT AND FAILED. ANALYSIS FOUND INSULATION ABRASION AT THE SUTURE SLEEVE. THE DAMAGE TO THE SUTURE SLEEVE OCCURRED AT THE TIME OF EXPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED NOISE. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28273 TENDRIL ST PERMANENT PACEMAKER ELECTRODE, NVN NVN ST. JUDE MEDICAL, INC., CRMD 1888TC/58

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention