BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223507 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03621
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 21, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS REVEALED AN INSULATION ABRASION AT 44.7 CM FROM THE DISTAL END. ONE OF THE TWO METAL RV CABLES WAS SEVERED AND MELTED AT THE TIP. THE LOCATION AND MODE OF THIS ABRASION IS CONSISTENT WITH THAT CAUSED BY FRICTION WITH THE CAN. FURTHER ANALYSIS ALSO REVEALED AN INTERNAL ABRASION BENEATH THE SVC SHOCK COIL, EXPOSING THE SENSING CABLE. THE INTERNAL ABRASION IS DUE TO FRICTION IN THE LUMEN FROM THE INSIDE OUTWARD.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW-UP VISIT. PATIENT NOTED FEELING PAIN WITH PACING. INTERROGATION OF THE DEVICE REVEALED TWO ALERTS, POSSIBLE OUTPUT CIRUCITY DAMAGE AND HIGH VOLTAGE LEAD IMPEDANCE OUT OF RANGE. THE PATIENT HAD A HIGH VOLTAGE THERAPY THAT DELIVERED THE FIRST SHOCK AND THEN ABORTED THE SECOND, DUE TO THE POSSIBLE OUTPUT CIRCUIT DAMAGE. NOISE WAS ALSO NOTED. THE LEAD WAS EXPLANTED.

    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 1581/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention