BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 2242757 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06258
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    May 31, 2011
    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 Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED REGARDING AN ALLEGED DAMAGE IN THE LEAD. THE PATIENT STATES SHE EXPERIENCED PAIN AND SUFFERING. THE SENSE/PACE PORTION WAS CAPPED AND REPLACED (B)(6) 2011. THE DEFIB PORTION REMAINS ACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7021/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention