BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2242624 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06074
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    June 23, 2011
    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
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE DISTAL PORTION OF LEAD WAS RETURNED, 54.9 CM LONG. ANALYSIS FOUND INTERNAL INSULATION ABRASION BETWEEN 13.6 CM AND 14.5 CM FROM THE DISTAL TIP. EXTERNAL INSULATION ABRASION WAS FOUND BETWEEN 44.6 CM AND 44.7 CM FROM THE DISTAL TIP; THIS DAMAGE IS CONSISTENT WITH FRICTION AGAINST THE ICD CAN. INTERNAL INSULATION ABRASIONS WERE FOUND BETWEEN 17.3 CM AND 19.0 CM FROM THE DISTAL TIP; ONE OF THE RV CONDUCTORS WAS COMPROMISED BETWEEN 18.5 CM AND 19.0 CM FROM THE DISTAL TIP.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER AFTER RECEIVING HV THERAPY. INTERROGATION FOUND AN ALERT FOR POSSIBLE HIGH VOLTAGE CIRCUIT DAMAGE WAS RECEIVED. LOW IMPEDANCE WAS OBSERVED AND CAPACITOR MAINTENANCE COULD NOT BE COMPLETED. HV THERAPY NOT AVAILABLE. LEAD FRACTURE SUSPECTED. LEAD WAS CAPPED AND REPLACED.

    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 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention (B)(4)