BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4863927 · Received June 23, 2015

    Report

    Report Number
    2938836-2015-27105
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 11, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IN THE HOSPITAL FOR UNRELATED ISSUE WHEN HV LEAD IMPEDANCE OOR WAS DETECTED. FLUOROSCOPY IMAGES HAVE CONFORMED EXTERNALIZED CONDUCTORS. DFT TEST WAS SUGGESTED. DTF TEST WAS SUCCESSFUL. NO ELECTRICAL ABNORMALITIES WERE DETECTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404994 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1580/65 0002192813

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR