BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3791196 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10368
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 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
    FL, 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 NON-SUSTAINED RV LEAD NOISE WAS OBSERVED. FURTHER NSLN EPISODES PRESENTED AFTER THE DEVICE WAS REPROGRAMMED AND WAS DETERMINED THAT IT WAS TRUE LEAD NOISE. NOISE WAS NOT REPRODUCIBLE IN CLINIC, AND THE PHYSICIAN ELECTED TO CONTINUE TO MONITOR THE LEAD. THE PATIENT WILL CONTINUE TO BE SEEN WITH ROUTINE FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268465 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR