BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM PASSIVE FIXATION

    MDR report key: 1895923 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04468
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 9, 2010
    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
    TN
    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 PACE/SENSE PORTION OF THE LEAD EXHIBITED HIGH IMPEDANCE. X-RAY DID NOT REVEAL ANY LEAD INTEGRITY ISSUES, ALTHOUGH FRACTURE WAS SUSPECTED. THE IMPEDANCE APPEARED NOT LONG AFTER THE PATIENT RECEIVED A SHOCK FOR SINUS TACHY DURING DIALYSIS TREATMENT. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7070/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention