BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053215 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05129
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED THAT A SETSCREW COULD HAVE BEEN LOOSE. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE. ONCE THE POCKET WAS REOPENED, IT WAS DISCOVERED THAT THE DISTAL SETSCREW FOR THE RV LEAD WAS FOUND TO BE LOOSE. THE SETSCREW WAS TIGHTENED WITH GOOD RESULTING NUMBERS. THERE WERE NO ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156703 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4135| 0184| N119| 4549