BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3920930 · Received July 8, 2014

    Report

    Report Number
    2938836-2014-13350
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 21, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE DEVICE CHANGE-OUT, THE NEW DEVICE ENTERED BACKUP VVI AFTER EXTERNAL DEFIBRILLATION WAS DELIVERED DUE TO AN UNSUCCESSFUL INDUCTION TEST. DEVICE CODE DOWNLOAD WAS SUCCESSFULLY PERFORMED. DEVICE WAS RE-INTERROGATED, AND LOW HV LEAD IMPEDANCE WAS OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398384 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention CD2311-36, 7093548