BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3080210 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-00927
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 8, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS NOTED AT 6.0-6.2CM, 6.3- 6.6CM, AND 6.8-7.0CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE COIL WAS MELTED AT 6.3- 6.8CM AND 6.8-7.0CM. EXTERNAL INSULATION ABRASION WAS NOTED AT 8.5-9.2CM FROM THE HELIX, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. THE ETFE COATING WAS INTACT AT THIS LOCATION. EXTERNAL INSULATION ABRASION WAS NOTED AT 48.5- 48.9CM FROM THE HELIX, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS DAMAGED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED TO THE OR FOR CHANGEOUT DUE TO NORMAL ERI. UPON EXPLANT, EXTERNALIZED CONDUCTORS WERE OBSERVED BETWEEN THE COILS OF THE LEAD. NO ELECTRICAL ANOMALIES WERE NOTED . THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181143 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention (B)(4)