BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3801349 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10999
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    January 26, 2014
    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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD WAS RETURNED IN THREE SEGMENTS FOR ANALYSIS. EXTERNAL INSULATION ABRASIONS WERE NOTED AT 6.0-6.1CM AND 6.1-6.4CM FROM THE PROXIMAL END, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THIS LOCATION. EXTERNAL INSULATION ABRASION WAS NOTED AT 38.5-38.8CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THIS LOCATION. INTERNAL INSULATION ABRASION WAS NOTED AT 14.8-16.5CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THIS LOCATION. EXTERNAL INSULATION ABRASION WAS NOTED AT 37.4-37.7CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE RV CONDUCTOR ETFE COATING WAS ABRADED AT THIS LOCATION. THE SVC CONDUCTOR ETFE COATING WAS ABRADED AT 42.2CM FROM THE DISTAL TIP. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF LOW HV LEAD IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN ER AFTER EXPERIENCING MULTIPLE HV THERAPIES FOR A VT/VF STORM. THE PATIENT HAD SYNCOPAL EPISODES. ALERTS FOR OVER CURRENT DETECTION AND POSSIBLE HIGH VOLTAGE LEAD ISSUE WERE OBSERVED. LOW, OUT OF RANGE, HV LEAD IMPEDANCE WAS NOTED. FURTHER INTERROGATION REVEALED THAT AT LEAST ONE CHARGE WAS ABORTED DUE TO THE HIGH VOLTAGE LEAD ISSUE. EXTERNALIZED CONDUCTORS WERE OBSERVED VIA DIAGNOSTIC IMAGING. LEAD AND DEVICE WERE EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278434 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 1207-36, 446125