BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3892802 · Received June 24, 2014

    Report

    Report Number
    2938836-2014-12338
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 21, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 HIGH, OUT OF RANGE HV LEAD IMPEDANCE WAS OBSERVED VIA REMOTE TRANSMISSION. PLANS ARE MADE TO REPROGRAM THE DEVICE. NO PATIENT SYMPTOMS WERE NOTED DURING THIS EVENT. LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368460 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR