BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052762 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04939
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS THOROUGHLY ANALYZED. VISUAL INSPECTION OF THE LEAD NOTED BOTH THE INTERNAL AND THE EXTERNAL INSULATION WAS ABRADED THROUGH TO THE CONDUCTOR COIL. MICROSCOPIC EVALUATION INDICATED THAT THE INSULATION DAMAGE WAS CAUSED BY LOCALIZED COMPRESSIVE STRESS ON THE INSULATION SURFACE. DUE TO THE LOCATION AND THE TYPE OF DAMAGE EXHIBITED, IT WAS CONCLUDED THAT THIS DAMAGE WAS CAUSED BY LEAD ENTRAPMENT IN THE CLAVICLE-FIRST RIB REGION. IN ADDITION, THE HIGH VOLTAGE CABLES WERE FOUND LOOPED OUT OF THE INSULATION; HOWEVER, THIS DAMAGE IS CONSISTENT WITH PULLING ON THE LEAD WITH FORCE DURING THE EXPLANT PROCEDURE. LABORATORY ANALYSIS CONFIRMED THAT THE LEAD DAMAGE DUE TO ENTRAPMENT IN THE CLAVICLE FIRST RIB REGION MOST LIKELY CONTRIBUTED TO THE CLINICAL OBSERVATIONS OF NOISE, OVERSENSING AND INAPPROPRIATE THERAPY.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS OVERSENSING NOISE WHICH THEN RESULTED IN THE DELIVERY OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). THE NOISE COULD BE REPRODUCED WITH EXERCISE. IN ADDITION, LOW SENSING MEASUREMENTS WERE ALSO NOTED. A REVISION WAS PERFORMED AND THIS LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. ONCE THE LEAD WAS EXPLANTED, THE PHYSICIAN NOTED AN INSULATION BREACH AND THE EXTERNALIZATION OF THE CONDUCTOR COILS UNDER THE SUTURE SLEEVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155596 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0174

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0175| T175| F141| 0174