BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1895583 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04331
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 30, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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

    ANALYSIS FOUND EXTERNAL INSULATION ABRASIONS BETWEEN 13CM AND 13.4CM AND BETWEEN 19.1CM AND 19.6CM FROM THE CONNECTOR PIN AS A RESULT OF FRICTION TO THE ICD CAN. THE COATINGS ON THE RV AND SVC CABLES WERE COMPROMISED. THIS DAMAGE COULD CAUSE THE REPORTED LOW IMPEDANCE. INTERNAL ABRASIONS WERE FOUND BETWEEN 19.8CM AND 26CM FROM THE DISTAL TIP. ONE OF THE RE CABLES WAS COMPROMISED. THIS DAMAGE COULD CAUSE THE REPORTED NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE LEAD THAT APPEARED AS SHORT RUNS OF VF. THE PATIENT DID NOT RECEIVE THERAPY. MONITORING WILL CONTINUE.

    Description of Event or Problem · 1

    EXTERNALIZED CONDUCTOR WAS SEEN ON FLUOROSCOPY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD SEVERAL EPISODES OF INAPPROPRIATE THERAPY SINCE (B)(6), 2011. THE LAST EPISODE SHOWS THAT THE PATIENT WENT INTO VF AND WAS FOUND UNRESPONSIVE WHEN THE AMBULANCE ARRIVED. THE PATIENT WAS PLACED ON A VENTILATOR AND WAS NOT EXPECTED TO SURVIVE. LEAD FRACTURE WAS SUSPECTED AS THE CAUSE OF THE NOISE AND THERAPY. FURTHER INFORMATION RECEIVED NOTES THAT THE PATIENT DID SURVIVE AND BECAME WELL ENOUGH FOR LEAD REPLACEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention