BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2950125 · Received February 8, 2013

    Report

    Report Number
    2938836-2013-00013
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 6, 2012
    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, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A NORMAL FOLLOW UP. LOW HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. WHEN PATIENT PRESENTED FOR A REPLACEMENT, LEAD IMPEDANCE WERE WITHIN NORMAL RANGE. IT WAS DECIDED TO REPLACE THE LEAD.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED THAT NOTES THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54719 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR