BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 4883518 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-06255
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    March 30, 2015
    Report Date
    May 5, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THE HELIX WAS PARTIALLY RETRACTED AND DRIED BLOOD WAS PRESENT IN THE HELIX HOUSING AND CONFIRMED THAT THE CATHODE CONDUCTOR COIL WAS FRACTURED AT THE DISTAL END OF THE TERMINAL PIN. MICROSCOPIC ANALYSIS CONFIRMED THAT THE LEAD BECAME FRACTURED DUE TO TORSIONAL OVERSTRESS. A LABORATORY TECHNICIAN TESTED THE HELIX MECHANISM AND FOUND IT WAS NONFUNCTIONAL, CONFIRMING THE CLINICAL OBSERVATION. BASED UPON THE CLINICAL OBSERVATIONS AND THE LABORATORY FINDINGS, WE BELIEVE THE CONDUCTOR COIL BECAME FRACTURED DURING ATTEMPTS TO EXTEND/RETRACT THE HELIX.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING ATTEMPTED IMPLANT, THE HELIX OF THIS LEAD FAILED TO EXTEND AS INTENDED AFTER IMPLANT. AS A RESULT, THE LEAD WAS REMOVED FROM THE PROCEDURE AND RETURNED FOR ANALYSIS. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED IN ABSENCE OF ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428464 INGEVITY IMPLANTABLE LEAD DTB CPI - DEL CARIBE 7741

    Patients

    Seq Age Sex Outcome Treatment
    1 7741