BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2153560 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06711
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WHEN THE PATIENT WAS IN THE HOSPITAL FOR AN UNRELATED ISSUE, THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE ROSE FROM 500 OHMS TO GREATER THAN 2000 OHMS. THE FLUOROSCOPY IMAGE SHOWED THAT THE LEAD TERMINAL PIN WAS NOT ALL THE WAY THRU THE DEVICE CONNECTOR BLOCK. A REVISION PROCEDURE WAS PERFORMED AND NORMAL IMPEDANCE MEASUREMENTS WERE SEEN WHEN THE LEAD WAS HOOKED UP TO A PACING SYSTEM ANALYZER. THE RV LEAD WAS RE-INSERTED INTO THE CONNECTOR BLOCK AND NORMAL MEASUREMENTS WERE OBSERVED. NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE REVISION PROCEDURE WERE REPORTED. THE DEVICE AND RV LEAD REMAIN IMPLANTED IN THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R S603| 4087| 4086