BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 4131769 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14159
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    May 21, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE COMPLETE LEAD WAS RETURNED. THE HELIX WAS FULLY RETRACTED AND THERE WAS DRIED BLOOD AND TISSUE NOTED IN THE HELIX AND HELIX HOUSING. AN X-RAY WAS PERFORMED AND THE INNER COIL AT THE TERMINAL PIN LOOKED NORMAL, AS EXPECTED HOWEVER, THE INNER COIL AT THE LEAD TIP SECTION OF THE LEAD WAS FRACTURED. NO THERAPY WAS AVAILABLE. EVIDENCE SUGGESTS THAT THE FRACTURE MOST LIKELY OCCURRED DURING EXTENSION OF THE HELIX.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO BE IMPLANTED AS THE HELIX MECHANISM WOULD NOT EXTEND. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A NEW LEAD WAS SUCCESSFULLY PLACED. THIS PRODUCT WAS RETURNED AND ANALYSIS WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612221 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7742

    Patients

    Seq Age Sex Outcome Treatment
    1 7742