BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 2993646 · Received March 7, 2013

    Report

    Report Number
    2938836-2013-00624
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 11, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    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

    INTERNAL INSULATION ABRASION WAS FOUND AT 22.3-23.3CM FROM THE CONNECTOR PIN. EXTERNAL INSULATION ABRASION WERE FOUND AT 28.7-30.7CM AND 36.0-36.4CM FROM THE ELECTRODE TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNAL INSULATION ABRASION WAS FOUND AT 46.9-47.2CM FROM THE ELECTRODE TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS ABRADED AT THE SAME LOCATION. THIS IS CONSISTENT WITH THE FIELD OBSERVATION OF LOW HV LEAD IMPEDANCE.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW HV LEAD IMPEDANCE WAS OBSERVED. LEAD DAMAGE SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97251 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7042/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1