BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL DX

    MDR report key: 3801030 · Received May 8, 2014

    Report

    Report Number
    2017865-2014-07532
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 18, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    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

    NEW INFORMATION NOTES THAT THE LEAD EXHIBITED OVERSENSING. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRAI L LEAD EXHIBTIED HIGH LEAD IMPEDANCE. THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277806 TENDRIL DX PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, CRMD 1388T/46

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention