BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2163122 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07049
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RIGHT VENTRICULAR LEAD REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SHORTLY AFTER IMPLANT, THIS RIGHT VENTRICULAR LEAD EXHIBITED IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS AND HIGH THRESHOLDS. THE PATIENT HAD AN INTRINSIC RHYTHM AND NO SYMPTOMS HAD BEEN EXPERIENCED BY THE PATIENT. A CHEST X-RAY WAS PERFORMED WHICH REVEALED THAT THE LEAD WAS STILL IN THE ORIGINAL SEPTAL POSITION. THE DECISION WAS MADE TO PERFORM A REVISION PROCEDURE TWO DAYS LATER. PRIOR TO THE REVISION PROCEDURE, THE IMPEDANCES OF THE RIGHT VENTRICULAR LEAD WERE 1,490 OHMS, AND THE THRESHOLDS WERE STILL INCREASED. DURING THE PROCEDURE, THE LEAD WAS REPOSITIONED INTO THE APEX AND NORMAL MEASUREMENTS WERE OBSERVED WITH IMPEDANCES AT 880 OHMS AND NORMAL THRESHOLDS. THE ATRIAL LEAD PARAMETERS WERE WITHIN NORMAL LIMITS AS WELL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention