BEUDAMED
    FDA Adverse Event Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 1895992 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04465
    Date Received
    November 10, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THAT THE OUTER INSULATION WAS ABRADED FROM THE INSIDE OUT BETWEEN 53.3CM AND 56.0CM FROM THE CONNECTOR PIN. THE INNER INSULATION AND PTFE INSULATIONS OF THE BLUE CABLES WERE FOUND INTACT. FURTHER EXAMINATION FOUND THAT A TINE WAS MISSING. THE FRACTURED AREA OF THE MISSING TINE IS LIKELY DUE TO AN INTRODUCER OR ANOTHER DEVICE INITIALLY DAMAGING THE AREA, AND OVER TIME, FRACTURE OCCURRED. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL SHOCKS DUE TO NOISE. DURING THE LEAD REPLACEMENT PROCEDURE, THE INSULATION WAS FOUND TO BE BROKEN AT THE TRICUSPID VALVE AREA. THE COMPETITOR'S ICD WAS REPOSITIONED FOUR MONTHS PRIOR DUE TO EROSION. THE PHYSICIAN STATED THAT HE DID NOT TOUCH THE LEAD AT THAT TIME.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)