BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3050044 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04404
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 20, 2013
    Report Date
    April 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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 AT THIS PATIENT'S POST-OPERATIVE WOUND CHECK THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A DECREASE IN PACING IMPEDANCES AND AN INCREASE IN CAPTURE THRESHOLDS. AN X-RAY WAS DONE AND NO OBVIOUS MOVEMENT OF THE LEAD WAS OBSERVED, SO A MICRODISLODGEMENT WAS SUSPECTED. THE PHYSICIAN WAS CONCERNED ABOUT THE STABILITY OF THE LEAD AS THE PATIENT HAS INTERMITTENT HEART BLOCK. HOWEVER, THE PATIENT DID NOT WANT TO UNDERGO ANOTHER PROCEDURE, SO THE OUTPUTS WERE FURTHER INCREASED AND THE PLAN WAS TO DO ANOTHER EVALUATION IN TWO WEEKS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE FIELD REPRESENTATIVE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAPTURE THRESHOLDS IMPROVED TO 1.5V AT 0.5MS, AND THE PACING OUTPUTS WERE ADJUSTED. NO FURTHER ISSUES IDENTIFIED AND THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149361 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR 4086| 4087| K063