BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3801384 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10961
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    July 30, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 14.1-15.2CM, 14.1-14.5CM, AND 27.7-29.2CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. INTERNAL INSULATION ABRASION WAS NOTED AT 10.3-11.0CM AND 26.1-27.0CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 25.3-25.4CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 25.1-25.4CM FROM THE DISTAL TIP. THE ETFE COATING WAS ABRADED AT THIS LOCATION. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE. THE REPORTED FRACTURE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED FOR A ROUTINE DEVICE CHECK, NOISE WITH AN ABORTED SHOCK WERE OBSERVED. NO NOISE COULD BE REPRODUCED WITH MANIPULATION. A LEAD FRACTURE WAS NOTED. THE LEAD WAS EXPLANTED AND REPLACED. PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278532 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention