BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 2014174 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01704
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 15, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS REVEALED SUTURE SLEEVE IMPRESSIONS ON THE INSULATION AT 15.8, 16.7 AND 17.5 CM FROM THE CONNECTOR END. THE DISTAL INSULATION WAS ALSO DAMAGED AT 15.8 CM. THE DAM AGE WAS CONSISTENT WITH THE SUTURE SLEEVE BEING TIED DOWN TOO TIGHTLY. THE DAMAGE TO THE DISTAL INSULATION WHICH RESULTED IN THE SHORTING OF THE COILS WOULD ACCOUNT FOR THE REPORTED SENSING AND HIGH THRESHOLD ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED A CAPTURE THRESHOLD OF 3.5 V, 0.5 MS. SENSING WAS LESS THAN 2.0 MV. AN INSULATION BREACH WAS NOTED CLOSE TO THE SUTURE SLEEVE. THE LEAD WAS REMOVED AND REP LACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2088TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention