BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1073232 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02390
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 7, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THAT ONLY A PARTIAL LEAD WAS RETURNED FOR ANALYSIS. AN ABRASION WAS FOUND ON THE OUTER INSULATION AT 20.5 CM FROM THE CONNECTOR PIN CONSISTENT WITH FRICTION TO ANOTHER DEVICE. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD DISLODGED AND WAS DOUBLE- COUNTING. THE LEAD WAS REPLACED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A INFUSOR PUMP WITH A CONDITION OF "CONSTANT ALARM". IT IS UNKNOWN WHEN OR AT WHAT POINT IN THE PROCESS THIS CONDITION OCCURRED. THE SERVICE TECHNICIAN REPORTED THAT THE REPORTED CONDITION INTERRUPTED DELIVERY DURING DEVICE EVALUATION. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1592/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention