BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 4062556 · Received January 14, 2014

    Report

    Report Number
    2017865-2014-08424
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    April 21, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLDS AND UNDER SENSING. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37528 TENDRIL STS PERMANENT PACEMAKER LEECTRODE DTB ST. JUDE MEDICAL INC., CRMD 2088TC/58

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention