BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1955066 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00044
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 12, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    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

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    A PORTION OF THE LEAD WAS INITIALLY RETURNED AND ANALYZED IN 2010. THE BALANCE OF THE LEAD WAS RETURNED IN FOUR SEGMENTS FOR ANALYSIS. SVC CONDUCTOR DAMAGE WAS FOUND AT 13CM FROM THE PIN CONSISTENT WITH CLAVICULAR CRUSH DAMAGE. THE ETFE COATING WAS DAMAGED AT THE SAME LOCATION. A 0.1CM LENGTH OF EXTERNAL INSULATION ABRASION AND SIGNS OF CLAVICULAR CRUSH DAMAGE WERE FOUND ON THE CAPPED SEGMENT. EXTERNAL INSULATION ABRASION WAS NOTED AT 10.2-13.0CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. THE ETFE COATING WAS INTACT AT THIS LOCATION. OTHER DAMAGES ARE CONSISTENT WITH THAT OCCURRING AT THE TIME OF EXPLANT.

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT THE CAPPED PORTION OF THE LEAD WAS EXPLANTED SOMETIME IN 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT X-RAY REVEALED AN INSULATION BREAK. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1571/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention V-243, 349132, 1688TC, JU148281