BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 2925820 · Received January 22, 2013

    Report

    Report Number
    2017865-2013-01067
    Event Type
    Death
    Date Received
    January 22, 2013
    Date of Event
    December 31, 2012
    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 Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASIONS WERE FOUND AT 11.1-11.3CM, 13.0-13.4CM, AND 21.7-22.2CM FROM THE CONNECTOR PIN CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. A SENSING AND A NON-FUNCTIONAL CONDUCTOR ETFE COATING WAS ABRADED AT TWO LOCATIONS. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF LOW IMPEDANCE WHEN THE LEAD WAS IN CONTACT WITH THE DEVICE CAN.

    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 THE PATIENT HAD A VF EPISODE. THE DEVICE DELIVERED THERAPY BUT THE THERAPY DID NOT BREAK THE RHYTHM. LOW HVLI WAS OBSERVED DURING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29964 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1561/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death (B)(4)