BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1896160 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05120
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    July 29, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THE PROXIMAL INSULATION ABRADED AT 25.5 CM FROM THE CONNECTOR PIN. THE LEAD WAS IMPLANTED ALONG WITH AN (B)(4) . THE DISTANCE TO THE ABRADED AREAS ON THE TWO LEADS MAKES IT LIKELY THAT THEY ABRADED AGAINST EACH OTHER. IF THE METAL IN THE LEADS CAME IN CONTACT, IT WOULD CAUSE THE REPORTED SENSING ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE. OVERSENSING AND A LEAD INSULATION DEFECT WERE OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention (B)(4)