BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2911480 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16802
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 21, 2012
    Report Date
    January 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE ALLEGATION AGAINST THE LEAD WAS NOT CONFIRMED. THE LEAD PASSED CONTINUITY TESTING BUT THE HELIX WOULD NOT EXTEND AND THE STYLET WOULD ONLY INSERT IN THE LEAD LUMEN TO 508 MILLIMETERS. THIS IS DUE TO DRIED BODY FLUID IN THE HELIX MECHANISM. THE CONDUCTOR COILS WERE DEFORMED AND THE INSULATION WAS CUT DUE TO THE USE OF A GRABBING TOOL. NO FURTHER ANALYSIS WAS PERFORMED AND THE LEAD WAS ARCHIVED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS FOUND TO HAVE FRACTURED AND WAS NOT CAPTURING. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH ANOTHER LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17473 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| L| R 4524| 4136| (B)(4)| 4087| 4135| 4024| K173| 4088| 5076