BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3854735 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11487
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS PRESENTED IN THE HOSPITAL FOR A ROUTING FOLLOW UP. DURING DEVICE INTERROGATION, NON-SUSTAINED LEAD NOISE EPISODES WERE OBSERVED. THE NOISE WAS NOT PRESENTED IN REAL TIME EMG AND WAS NOT REPRODUCED WITH POCKET MANIPULATION. ALL ELECTRICAL MEASUREMENTS WERE STABLE AND IN RANGE. LEAD WAS CAPPED AND REPLACED. PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331579 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention