BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1771463 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12548
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE ATRIAL AND VENTRICULAR LEAD REMAIN IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT ONE WEEK POST IMPLANT, THE PATIENT WITH THIS PACING SYSTEM WAS EXPERIENCING PALPITATIONS AND STIMULATION WHEN THE DEVICE WAS PACING. UPON INTERROGATION OF THE DEVICE, NO CAPTURE AND NO SENSING IN THE ATRIUM WAS OBSERVED. IN ADDITION, THE VENTRICULAR AMPLITUDE WAS VARIED AND THE LEAD WAS CAPTURING IN THE ATRIUM. A CHEST X-RAY WAS PERFORMED AND REVEALED THAT BOTH THE ATRIAL AND VENTRICULAR LEADS HAD DISLODGED. A REVISION PROCEDURE WAS TO BE PERFORMED IN THE NEAR FUTURE. NO 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 Life Threatening