BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2040721 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01510
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 31, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD RECEIVED INAPPROPRIATE SHOCKS DUE TO NOISE AND OVERSENSING. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVED THE SHOCKS. THE PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2000 OHMS. A MAGNET WAS PLACED OVER THE DEVICE TO INHIBIT THE INAPPROPRIATE SHOCKS; HOWEVER, THE MAGNET SLIPPED OUT OF POSITION AND THE PATIENT RECEIVED ADDITIONAL SHOCKS. THE HEALTH CARE PROFESSIONAL (HCP) ELECTED TO PROGRAM THE DEVICE TO MONITOR ONLY. IT WAS NOTED THAT THE NOISE SEEMED TO LESSEN WITH ISOMETRICS AND THE PATIENT IS NOT PACER DEPENDENT. TECHNICAL SERVICES (TS) DISCUSSED THIS IS LIKELY A CONNECTION ISSUE OR A LEAD FRACTURE. THE PHYSICIAN INDICATED HE WAS GOING TO SCHEDULE THE PATIENT FOR A REVISION PROCEDURE. AT THIS TIME, NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CONFIRMED THAT THIS LEAD WAS FRACTURED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED. 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 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention E110| 4136| 0158