BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1050863 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01805
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 9, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    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.

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THE OUTER INSULATION ABRADED AND ONE OF THE SENSING CABLES ABRADED AT 23.0 CM FROM THE CONNECTOR PIN DUE TO FRICTION WITH THE ICD CAN. THIS DAMAGE COULD CAUSE THE OVERSENSING REPORTED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE EPISODES. DURING REVISION, AN INSULATION DEFECT WAS CAUSED BY A SCALPEL. THE LEAD WAS EXPLANTED.

    Description of Event or Problem · 1

    ON MAY 7, 2010, A DOCTOR REPORTED THAT A SYBRONPRO TL IMPLANT FRACTURED THREE MONTHS AFTER PLACEMENT.

    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