BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 2240197 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05642
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    February 21, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. RELIABILITY LABORATORY TECHNICIAN, (B)(4). (B)(4) FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND MEDICAL ADHESIVE ON THE RING ELECTRODE, CAUSING THE LEAD TO EXHIBIT HIGH LEAD IMPEDANCE IN THE BI-POLAR CONFIGURATION.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, 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 DURING IMPLANT, THE LEAD EXHIBITED UNACCEPTABLE THRESHOLDS. THE LEAD WAS NOT IMPLANTED AND REPLACED.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR