BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1852692 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14589
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    June 29, 2010
    Report Date
    August 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS EXPLANTED DUE TO INFECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT AT INITIAL IMPLANT OF THIS PACEMAKER, THE LEADS WERE REVERSED IN THE HEADER. THIS CAUSED ATRIAL FLUTTER TO BE STORED IN THE DEVICE AS EPISODES OF VENTRICULAR TACHYCARDIA, AS WELL AS NO PACING IN THE VENTRICULAR CHAMBER. THE PATIENT FELT CONSTANT FATIGUE, LACK OF ENERGY AND FELT TIRED ALL THE TIME. A PROCEDURE WAS DONE REMOVING THE LEADS AND REPLACING THEM BACK IN THE CORRECT POSITION IN THE DEVICE HEADER AND THE PATIENT IMMEDIATELY FELT BETTER, AND THE ATRIAL FLUTTER WAS RESOLVED. TO DATE, THERE HAVE BEEN NO ADDITONAL ADVERSE PATIENT EFFECTS 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 81 YR Required Intervention 1298| 4088| (B)(4)| S603