BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3220258 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04150
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 3, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EXTERNAL INSULATION ABRASION WAS NOTED AT 7.5-7.7CM FROM THE CONNECTOR PIN, CONSISTENT WITH FRICTION TO THE ICD CAN. THE COIL WAS VISIBLE AT THE SAME LOCATION. THIS IS CONSISTENT WITH OBSERVATION FROM THE FIELD OF LOSS OF CAPTURE IF THE EXPOSED COIL WERE TO COME IN CONTACT WITH THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYMPTOMATIC (PRESYNCOPAL) PATIENT PRESENTED TO THE ER DUE TO LOSS OF CAPTURE WHICH WAS OBSERVED ON THE LEAD. VIA DIAGNOSTIC IMAGING, NO ANOMALIES WERE NOTED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319432 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention