BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1873900 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18219
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL ANALYSIS REVEALED THAT THE COMPLETE LEAD WAS RETURNED AND THERE WERE SETSCREW MARKS NOTED ON ALL TERMINAL CONNECTORS. THE TRILUMEN INSULATION HAD AN ABRASION 31 CENTIMETERS FROM THE IS-1 PIN. ELECTRICAL CONTINUITY TESTING WAS PERFORMED WITH MANIPULATION ON ALL CONDUCTIVE PATHWAYS. THIS LEAD WAS FOUND TO BE ELECTRICALLY CONTINUOUS. THE TRILUMEN INSULATION ABRASION WAS FURTHER ANALYZED AND THE RATE/SENSE NEGATIVE COIL AND DISTAL HIGH VOLTAGE CONDUCTORS WERE EXPOSED, THE PROXIMAL CABLE APPEARED TO BE INTACT AND NO CONDUCTORS EXPOSED. ANALYSIS REVEALED INSULATION DAMAGE AND CONDUCTOR EXPOSURE, HOWEVER, ALL CONDUCTIVE PATHS SHOW CONTINUOUS INDICATING THAT NO FRACTURE HAD OCCURRED. DUE TO LOCATION AND TYPE OF DAMAGE IT WAS DETERMINED THAT IT WAS MOST LIKELY DUE TO CLAVICLE FIRST/RIB ENTRAPMENT.

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ON-GOING. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WHICH RESULT IN INAPPROPRIATE SHOCKS ALONG WITH INCREASED PACING THRESHOLDS AND CHANGES IN PACING IMPEDANCE MEASUREMENTS. IT WAS DETERMINED THAT THE LEAD WAS FRACTURED. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THIS PRODUCT WAS EXPLANTED AND REPLACED. 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 0186

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention H170| 4543| 4076| 0186