BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2984363 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00341
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 20, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. A PARTIAL LEAD WAS RETURNED FOR ANALYSIS. AN EXTERNAL INSULATION ABRASION WAS FOUND AT 6.6-7.5CM FROM THE DISTAL END. THE ETFE COATING WAS INTACT AT THIS LOCATION. AN INTERNAL INSULATION ABRASION WAS FOUND UNDER THE RV SHOCK COIL AT 5.4-5.6CM FROM THE DISTAL END. THE ETFE COATING WAS INTACT AT THIS LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DESCREASE IN SENSING WAS OBSERVED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88073 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR