BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3220298 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04177
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    February 14, 2013
    Report Date
    April 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER AND MAUDE REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SECOND DFT TEST, A SUSPECTED SHORT CIRCUIT OF THE ICD DUE TO LEAD FAILURE CAUSED THE DEVICE TO SWITCH TO BACKUP VVI. THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE AND THE LEAD WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320252 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention V-243, (B)(4)