BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3053220 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05202
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PORTION OF THE LEAD HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE LEAD WAS RETURNED SEVERED AT 150 MM FROM THE TERMINAL PIN AND ONLY THE PROXIMAL SEGMENT WAS RETURNED. THE RETURNED PORTION OF THE LEAD WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THAT SEGMENTS' ELECTRICAL PERFORMANCE WAS INTACT. NO FURTHER TESTING WAS PERFORMED. ANALYSIS COULD NOT CONFIRM THE CLINICAL ALLEGATIONS OBSERVED IN THE FIELD WITH THE RETURNED PORTION OF THE LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ALONG WITH LOSS OF CAPTURE AT MAXIMUM OUTPUTS. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE THE RV LEAD WAS SURGICALLY ABANDONED DUE TO A FRACTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155326 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| L| R 4479| 1290| 4087