BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3801361 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10959
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 5, 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
    AR, 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 A SYMPTOMATIC PATIENT PRESENTED TO CLINIC AFTER RECEIVING INAPPROPRIATE HV THERAPY. THE PATIENTS RHYTHM AT THE TIME OF THE SHOCK WAS ATRIAL FIBRILLATION WITH A RAPID VENTRICULAR RATE. THE SHOCK WAS INAPPROPRIATE, BUT THE THERAPY CONVERTED THE PATIENT. UPON INVESTIGATION, THE DEVICE REPORTED OVER CURRENT DETECTION ERROR AND LOW, OUT OF RANGE HV LEAD IMPEDANCE DURING THERAPY. FRACTURE WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278462 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7001/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 2207-36, 503586