BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3781971 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10043
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 11, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED DUE TO UNRELATED PAIN AT THE SITE OF THE DEVICE. UPON INTERROGATION, EPISODES OF VF DUE TO NOISE WERE OBSERVED. THE NOISE WAS REPRODUCIBLE IN CLINIC. FRACTURE WAS ALSO NOTED. LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259417 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention