BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3790102 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-10032
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 22, 2014
    Report Date
    February 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD BEEN EXPERIENCING CHEST PAIN OVER THE PAST TWO WEEKS. TODAY, A CHEST X-RAY (CXR) SHOWED THIS RIGHT VENTRICULAR (RV) LEAD WAS STRAIGHT DOWN. ALL LEAD DIAGNOSTICS WERE NORMAL AND AN ECHOCARDIOGRAM AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN WERE PERFORMED AND THERE WAS NO EVIDENCE OF LEAD PERFORATION OR PERICARDIAL EFFUSION. HOWEVER, A REVISION PROCEDURE WAS PERFORMED TO PLACE THE LEAD IN A MORE OPTIMAL POSITION. THE SCREW WAS RETRACTED AND THE LEAD WAS PULLED BACK. WHILE PULLING LEAD BACK, THE PHYSICIAN NOTED SOME RESISTANCE WHICH CONVINCED HIM OF AN RV PERFORATION. THE LEAD WAS SUCCESSFUL REPOSITIONED WITH NORMAL DIAGNOSTICS. ONE MONTH LATER, THE PATIENT PRESENTED WITH ORTHOSTATIC HYPOTENSION, DEHYDRATION AND SYNCOPE. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO RECOVER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266556 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| O 0293| E160