BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2040133 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-02762
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THIS LEAD WAS THOROUGHLY ANALYZED. THE HELIX WAS ABLE TO FULLY EXTEND. THIS LEAD MET SPECIFICATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A PROCEDURE TO IMPLANT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD IN AN APICAL POSITION, THIS LEAD PERFORATED. THE PATIENT HAD DYSPLASIA AND A RIGHT VENTRICULAR APICAL ANEURISM. THE PHYSICIAN GOT THE LEAD IN THE APICAL POSITION AND GOT NUMBERS, BUT AS IT WAS SCREWED IN, THE COILS LOOKED LIKE THEY WERE INCH-WORMING WITH EVERY HEART BEAT. ALTHOUGH THE NUMBERS WERE GOOD, THIS DIDN'T LOOK RIGHT, SO THE PHYSICIAN PULLED IT OUT. THE PHYSICIAN THINKS HE PUT THE LEAD INTO THE ANEURISM, AND WHEN HE PULLED THE LEAD OUT, THE ANEURISM RUPTURED. THE PHYSICIAN SAID THAT HE BELIEVED THIS WAS DUE TO PATIENT ANATOMY, AND NOT TO THE LEAD. HE DECIDED TO IMPLANT THE LEAD IN A DIFFERENT LOCATION, AND SO HE NEEDED A LONGER LEAD. A LONGER LEAD WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THEY DID A PERICARDIALCENTESIS THE FOLLOWING MORNING AND THE PATIENT WAS FINE. HE DID NOT DEVELOP TAMPONADE. THE LEAD THAT PERFORATED THE PATIENT'S HEART WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Other