BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2083865 · Received May 11, 2011

    Report

    Report Number
    2017865-2011-03312
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    February 21, 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
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED ANALYSIS OF THE LEAD FOUND INSIDE OUT ABRASIONS AT 14.4CM TO 16CM FROM THE HELIX END. THE ETFE COATING ON THE RING ELECTRO DE CABLE WAS COMPROMISED AT THIS LOCATION BUT THE INNER INSULATION FOR THE DISTAL COIL WAS NOT DAMAGED. FURTHER ANALYSIS ON THE RV SHOCK COIL FOUND INSIDE-OUT ABRASION AT 3.8CM TO 6.6CM FROM THE HELIX END. THE ETFE COATING ON THE RING ELECTRODE CABLE WAS S ALSO COMPROMISED AT THE SAME LOCATION. THIS COULD CAUSE THE REPORTED NOISE AND DELIVER INAPPROPRIATE SHOCKS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO NOISE. IT WAS FOUND THAT THE LEAD HAD INSULATION DAMAGE, EXPOSING THE CABLE OUTSIDE THE OUTER INSULATION. THE LEAD WAS EXPLANTED.

    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 51 YR Required Intervention (B)(4)