BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3080235 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-00897
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    January 19, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    NEW INFORMATION INDICATED THE LEAD WAS CAPPED AND REPLACED. THE PATIENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION, EPISODES OF NOISE WERE OBSERVED ON THE LEAD. THE PHYSICIAN DECIDED TO MONITOR THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182973 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention