BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM PASSIVE FIXATION

    MDR report key: 1223776 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03501
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    November 6, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT, DECREASE IN R-WAVES, AN INCREASE IN THRESHOLD AND LOW IMPEDANCE WERE OBSERVED. X-RAY SUGGESTED MICRO-DISLODGEMENT. A LEAD REPOSITIONING WAS PLANNED. WHEN PATIENT RETURNED FOR ADDITIONAL FOLLOW-UPS, THRESHOLDS HAD COME DOWN, ALTHOUGH PREVIOUS FOLLOW-UP HAD SHOWN FURTHER INCREASE IN VALUES. IN 2008, PATIENT PRESENTED TO THE CLINIC WITH HIGH THRESHOLD. LEAD WILL BE REPOSITIONED IN THE UPCOMING WEEKS.

    Description of Event or Problem · 1

    THE LEAD WAS REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7071/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention