BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4863540 · Received June 23, 2015

    Report

    Report Number
    2938836-2015-27302
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 14, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE RV LEAD. PHYSICIAN SUSPECTED CLAVICLE CRUSH, WITH INCONCLUSIVE ISOMETRICS TEST AND NO IMAGING. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT IS DOING WELL POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405707 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1580/65 0002204822

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention