BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3090043 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01075
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 18, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PINS MEASURING 27.9CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 19.2-19.5CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THE SAME LOCATION. WITHOUT RETURN OF THE ENTIRE LEAD A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT LEAD FRACTURE WAS OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN THE HOSPITAL AFTER RECEIVING THE VIBRATORY PATIENT NOTIFIER. HIGH HV LEAD IMPEDANCE WAS OBSERVED ON RV-CAN AND RV-SVC VECTORS. LEAD TO BE REPLACED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE PATIENT PRESENTED FOR FOLLOW-UP AND NO FURTHER ANOMALIES WERE NOTED. LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192416 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention (B)(4)