BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1954830 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00191
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 12, 2010
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED INSULATION ANOMALY AND NOISE WERE CONFIRMED IN THE LABORATORY. ANALYSIS FOUND THE OUTER INSULATION ABRADED AND BOTH RV CABLES WERE MELTED AT 18.5CM FROM CONNECTOR PIN. THE RV SHOCK COIL WAS KINKED AT 60CM FROM CONNECTOR PIN. THE ABRASION IS CONSISTENT WITH THAT OF FRICTION TO THE CAN. A SHORT CIRCUIT COULD HAVE OCCURRED BETWEEN THE DEVICE'S CAN AND THE RV CABLES RESULTING IN LONG CHARGE TIME AND NOISE.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO A FOLLOW-UP DUE TO EXTENDED CHARGE TIME. NOISE WAS SEEN ON THE IEGM DURING CHARGING. A LEAD ABRASION AND FRACTURE WERE OBSERVED DURING MACROSCOPIC EXAM. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7002/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention