BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4820236 · Received June 4, 2015

    Report

    Report Number
    2938836-2015-26220
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    March 25, 2015
    Report Date
    April 2, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS CAPPED AND REPLACED DUE TO INSULATION ANOMALY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361358 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1590/60 0002121779

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention