BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4840242 · Received June 10, 2015

    Report

    Report Number
    3009448963-2015-00339
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    CAMERON HEALTH INC.
    Product Code
    NVY
    UDI-DI
    00802526530906
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS PENDING ADDITIONAL INFORMATION FROM THE FIELD TO CONFIRM FINAL OUTCOME.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QA LAB, A THOROUGH EVAL OF THE LEAD WAS PERFORMED. VISUAL INSPECTION OF THE LOAD CONFIRMED THE COMPLETE LEAD WAS RETURNED. CUTS WERE NOTED IN THE INSULATION. BLOOD/BODY FLUID WAS NOTED IN THE LUMEN. THE ELECTRODE BODY WAS TWISTED ALONG ITS WHOLE LENGTH AND EXTREMELY TWISTED AND KNOTTED ON THE PROXIMAL END. THE INSULATION WAS TORN IN A FEW PLACES AND THE CONDUCTOR COILS WERE STRETCHED AND DEFORMED. TESTING AND X-RAY PHOTOS SHOW THAT THE SENSE B, HIGH VOLTAGE PROXIMAL CABLES AND HIGH VOLTAGE DISTAL CABLES WERE ALL FRACTURED NEAR THE TERMINAL AREA. THE SENSE A CABLE WAS PARTIALLY FRACTURED. RESISTANCE TESTING WAS COMPLETED AND DID NOT PASS DUE TO THE DAMAGED CONDUCTORS. THE DAMAGE CONFIRMED IN ANALYSIS IS CONSISTENT WITH DAMAGE DUE TO TWIDDLER'S SYNDROME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT REPORTED RECEIVING A SHOCK FROM HER SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) IN THE EARLY-MORNING HOURS. THE S-ICD SYSTEM WAS CHECKED AND UPON INTERROGATION, A HI IMPEDANCE ALERT WAS NOTED. AN X-RAY REVEALED THE ELECTRODE WAS COILED UP IN A KNOT IN THE POCKET. DATA FROM THE DEVICE MEMORY WAS REVIEWED BY BOSTON SCIENTIFIC ENGINEERING. A POSSIBLE OPEN CIRCUIT WAS OBSERVED AND POSSIBILITY OF ELECTRODE WIRE DAMAGE FROM THE PATIENT BEING A TWIDDLER. THE DEVICE SUMMARY REPORT SHOWED NO SHOCKS DELIVERED, HOWEVER SHOCKS WERE ATTEMPTED AND THE PATIENT REPORTED FEELING A SHOCK. THE ELECTRODE WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376480 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH INC. 3010 00802526530906

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R