BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 12334118 · Received August 17, 2021

    Report

    Report Number
    2017865-2021-27913
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    June 20, 2021
    Report Date
    October 27, 2021
    Manufacturer
    ABBOTT
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO X-RAY VIEWS HAVE BEEN PROVIDED TO ABBOTT, SO WE CANNOT FULLY CONFIRM THE EVENT. HOWEVER, BASED ON THE EVENT DESCRIPTION WE REGARD THIS AS A CASE OF EXTERNALIZED CABLES. NO FURTHER ANALYSIS CAN BE PERFORMED SINCE THE LEAD WILL NOT BE RETURNED TO ABBOTT FOR ANALYSIS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT NOISE WAS ALSO OBSERVED ON THE RV LEAD. DURING A ROUTINE DEVICE EXCHANGE THE PHYSICIAN DECIDED NOT TO PERFORM INTERVENTION TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    NO X-RAY VIEWS HAVE BEEN PROVIDED TO ST. JUDE MEDICAL SO WE CANNOT FULLY CONFIRM THE EVENT. HOWEVER, BASED ON EVENT DESCRIPTION WE REGARD THIS AS A CASE OF EXTERNALIZED CABLES. NO FURTHER ANALYSIS CAN BE PERFORMED SINCE THE LEAD WILL NOT BE RETURNED TO ST. JUDE MEDICAL FOR ANALYSIS.

    Description of Event or Problem · 1

    DURING AN IN CLINIC FOLLOW-UP, OVERSENSING WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. A PREVIOUSLY X-RAY WAS REVIEWED AND EXTERNALIZED CONDUCTORS WERE OBSERVED. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228876 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ABBOTT 1572/65 2997508

    Patients

    Seq Age Sex Outcome Treatment
    1