BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3080087 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-00944
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 5, 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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASIONS WERE FOUND AT 16.4-16.7CM AND 18.0-18.3CM FROM THE IS-1 PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS ABRADED AT THE 16.4- 16.7CM ABRASION LOCATION.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR DEVICE UPGRADE. NOISE WAS NOTED ON THE LEAD VIA MERLIN.NET. HOWEVER, PRE-OP TESTING DIDN'T REVEAL NOISE. THE LEAD WAS EXPLANTED AND REPLACED WITHOUT ANY COMPLICATIONS. THE PATIENT'S CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182834 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention