BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2984340 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00269
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 11, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS FOUND AT 12.4-12.5CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. INTERNAL INSULATION ABRASION WAS FOUND AT 6.9-8.1CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. MEDICAL DEVICES: 1056T, (B)(4). DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87038 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention (B)(4), (B)(4), 1688T, (B)(4),