BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDK

    MDR report key: 4062574 · Received January 14, 2014

    Report

    Report Number
    2017865-2014-08351
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    October 26, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37514 TENDRIL SDK PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL INC., CRMD 1688TC/46

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention