BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2042394 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01975
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED AND THE PACE SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED. 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 THIS RIGHT VENTRICULAR (RV) LEAD HAD INCREASING PACING THRESHOLDS AND PACING IMPEDANCE VARYING FROM 1000-2000 OHMS. AT A FOLLOW-UP APPOINTMENT, THE IMPEDANCE WAS GREATER THAN 2000 OHMS. NOISE WAS ALSO OBSERVED, LEADING TO OVERSENSING. THE PATIENT WAS HOSPITALIZED. NO FURTHER 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 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention F110| 4473| 0147| 1861