BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 1864095 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15898
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE CHANGE-OUT PROCEDURE TOOK PLACE. A NEW RA LEAD WAS ATTEMPTED TO BE IMPLANTED BUT WAS UNSUCCESSFUL DUE TO STENOSIS OF THE LEFT SUBCLAVIAN VEIN. THE CHRONIC RA LEAD WAS NOT SURGICALLY ABANDONED AND CAPPED. INSTEAD IT WAS CONNECTED TO THE RA PORT TO SAVE ROOM IN THE POCKET BY NOT REQUIRING A LEAD CAP. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE RIGHT ATRIAL (RA) LEAD WAS EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCES GREATER THAN 2000 OHMS. IT ALSO HAD LOW IMPEDANCES LESS THAN 200 OHMS. ADDITIONALLY, THERE WAS NOISE AND LOSS OF CAPTURE. THE LEAD PLANNED TO BE SURGICALLY ABANDONED AT THE DEVICE CHANGE-OUT PROCEDURE. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 0184| A155| 4086