BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2053247 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-05899
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE NOISE COULD NOT BE REPRODUCED WITH POCKET MANIPULATION OR ISOMETRICS. IT WAS NOTED THAT THE NOISE WAS OVERSENSED AND RESULTED IN GREATER THAN 2 SECOND PAUSES IN PACING. ALL OTHER LEAD MEASUREMENTS WERE NOTED TO BE NORMAL. TECHNICAL SERVICES (TS) RECOMMENDED A CHEST X-RAY TO CHECK FOR GROSS LEAD ISSUES. IT WAS LATER NOTED THAT A REVISION PROCEDURE WAS PERFORMED. THE PHYSICIAN ALLEGED A DEVICE HEADER ISSUE, ALTHOUGH IT WAS CONFIRMED THAT THE DEVICE WAS NOT IMPLANTED SUB-PECTORALLY, AND THERE WERE NO VISUAL OBSERVATIONS OF A HEADER ISSUE. THE LEADS WERE TESTED DURING THE PROCEDURE AND WERE NOTED TO TEST OKAY, THUS THE PHYSICIAN ELECTED TO ONLY REPLACE THE DEVICE. 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 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention N119| 4592| 0184| 4543