BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041817 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02909
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE LEAD RETURNED AND UNDERWENT DETAILED ANALYSIS. VISUAL INSPECTION NOTED THAT A VERY KINKED UNKNOWN GREY HANDLED STYLET WAS RETURNED INSERTED IN THE LEAD. THE PROXIMAL END OF THE DISTAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION WITH MEDICAL ADHESIVE NOTED. SETSCREW MARKS WERE NOTED ON THE IS-1 TERMINAL PIN AND DISTAL HIGH VOLTAGE TERMINAL PIN. NO DISCERNABLE SETSCREW MARKS WERE NOTED ON THE IS-1 RING. THERE APPEARED TO BE SOME TYPE OF HEAT DAMAGE, MOST LIKELY FROM CAUTERY OR LASER FROM THE EXTRACTION. THE GORE WAS DAMAGED, BLACKENED AND MELTED IN MANY PLACES. HELIX WAS SLIGHTLY BENT. THERE WAS BLOOD/BODY FLUID NOTED IN THE LUMENS AND THE HELIX HOUSING. MICROSCOPIC ANALYSIS REVEALED THE TRILUMEN INSULATION DAMAGE THROUGH TO THE DISTAL HIGH VOLTAGE (HV) LUMEN 110-125 MM FROM THE TERMINAL PIN. THE DAMAGE APPEARED AS A SMOOTH SURFACE ABRASION WITH JAGGED EDGES. THERE WAS WEBBING DAMAGE NOTED THROUGH TO THE RS- LUMEN IN THIS AREA AS WELL. THE DISTAL HV CABLE GORE WAS TORN/ABRADED IN THIS AREA. THE DISTAL HV CABLE CONDUCTOR HAD BEEN RUBBED AND APPEARED SLIGHTLY FLATTENED. DETAILED ANALYSIS UNABLE TO CONFIRM THE LEAD FRACTURE. DUE TO THE LOCATION AND TYPE OF DAMAGE IT WAS LIKELY CAUSED BY LEAD ON CAN CONTACT, COUPLED WITH PRESSURE.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED AND DETAILED ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXPLANTED AS IT WAS FRACTURED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 153 MO Required Intervention MISMATCH| E102| 0180