BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 7619953 · Received June 20, 2018

    Report

    Report Number
    2124215-2018-10742
    Event Type
    Injury
    Date Received
    June 20, 2018
    Date of Event
    June 1, 2018
    Report Date
    October 1, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCTS WILL NOT BE RETURNED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION NOTED THE LEAD WAS RETURNED IN TWO SEGMENTS. A MIDDLE SEGMENT OF LEAD MEASURED 4 CM AND THE TIP SEGMENT WAS 6.5 CM IN LENGTH AND INCLUDED THE SHOCKING COILS OVER WHICH THE GORE COATING WAS VERIFIED TO BE FULLY INTACT. THE TERMINAL PIN END OF THE LEAD WAS NOT RETURNED. ANALYSIS CONFIRMED THERE IS NO PART OF THE RETURNED SEGMENTS OF LEAD MISSING.

    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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND ASSOCIATED RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS WERE EXPLANTED DUE TO INFECTION. IT WAS REPORTED THE RIGHT ATRIAL (RA) LEAD WAS NOT ABLE TO BE REMOVED FROM THE PATIENT AND WAS THEREFORE SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION ABOUT THIS CASE. THE PHYSICIAN REPORTED THE OGRE COVERING ON THE RV LEAD APPEARED DAMAGED AFTER THE LEAD WAS REMOVED FROM THE PATIENT AND IT WAS SUSPECTED A PORTION REMAINED WITHIN THE PATIENT¿S BODY. A FOREIGN OBJECT WAS OBSERVED UNDER ECHOCARDIOGRAPHY. THE LEAD WAS UNDERGOING CULTIVATION TESTING DUE TO THE INFECTION, BUT WAS PLANNED TO BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. PHOTOGRAPHS OF THE EXPLANTED LEAD WERE SUBMITTED FOR REVIEW, AND THE GORE COVERING APPEARED TO BE INTACT; HOWEVER, THE LEAD WOULD NEED TO BE RETURNED TO CONFIRM THIS. IT WAS LATER NOTED THE RESULT OF CULTURE TEST FOR INFECTION WAS NEGATIVE ON THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460914 ENDOTAK RELIANCE IMPLANTABLE LEAD DTB CPI - DEL CARIBE 0692

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 0692| 4674| 7735| G447