BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1830767 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03288
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 9, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Adverse Event
    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 ANALYSIS CONFIRMED THE SENSING ANOMALY. THE SENSING COIL OF THE IS-1 CONNECTOR WAS FRACTURED AT 7CM FROM THE CONNECTOR PIN. THE OUTER INSULATION OF THE IS-1 CONNECTOR LEG WAS DAMAGED IN THE SAME AREA. THE INSULATION DAMAGE IS CONSISTENT WITH FRICTION TO THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED TWO INAPPROPRIATE SHOCKS. THE ECG REVEALED NOISE. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD.

    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 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention