BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 2240460 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05689
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    June 20, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS REVEALED THAT THE LEAD WAS FRACTURED AT 14.3 CM TO 17.8 CM FROM THE END OF THE CONNECTOR PIN WHERE THE LEAD WAS COMPRESSED AND BOTH DISTAL AND PROXIMAL INSULATIONS WERE BROKEN. THIS TYPE OF CRUSHING IS CONSISTENT WITH DAMAGE CAUSED BY CLAVICLE CRUSH. SINCE THE DISTAL INSULATION WAS BROKEN THE COILS COULD CONTACT EACH OTHER CAUSING THE REPORTED NOISE, LOW IMPEDANCE AND OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED LESS THAN 200 OHMS IMPEDANCE AND OVERSENSING. THE LEAD HAD CLAVICULAR CRUSH. THE LEAD WAS REMOVED AND REPLACED.

    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/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention (B)(4)