BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 3936008 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-13903
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 13, 2014
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT IN OUR QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL EXAMINATION OF THE LEAD REVEALED THAT THE HELIX MECHANISM WAS PARTIALLY RETRACTED AND THERE WAS DRIED BLOOD/BODY FLUID WITHIN THE HELIX AND HELIX HOUSING, AS WELL AS WITHIN THE WINDOW/NECK REGION OF THE LEAD ITSELF. TISSUE WAS ALSO IDENTIFIED WITHIN THE HELIX MECHANISM. X-RAY EXAMINATION REVEALED AN INNER COIL FRACTURE AT THE DISTAL REGION OF THE LEAD¿S TERMINAL PIN. FURTHER ANALYSIS OF THE LEAD REVEALED THAT THERE WERE MULTIPLE COMPRESSION MARKS AND TEARS IN THE ETHYLENE TETRAFLUOROETHYLENE (ETFE) INSULATION COVERING THE INNER COIL ON THE DISTAL SIDE OF THE FRACTURE. THE TYPE OF FRACTURE IS INDICATIVE OF TORSION OVERLOAD AS A RESULT OF HELIX EXTENSION/RETRACTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS RIGHT ATRIAL (RA) LEAD, THE LEAD¿S HELIX MECHANISM WAS FIRST TESTED OUTSIDE THE PATIENT¿S BODY. A TOTAL OF EIGHT TURNS RESULTED IN EXTENSION OF THE HELIX AND EIGHT TURNS FULLY RETRACTED THE HELIX. WHEN THE RA LEAD WAS BEING POSITIONED IN THE ATRIUM, THE HELIX COULD NOT BE EXTENDED OUTSIDE OF THE HELIX HOUSING AFTER APPROXIMATELY 35 TURNS WITH THE LEAD¿S FIXATION TOOL. THE RA LEAD WAS THEN REMOVED FROM THE PATIENT¿S HEART AND THE HELIX MECHANISM WAS TESTED OUTSIDE OF THE PATIENT¿S BODY. THE HELIX MECHANISM COULD NOT BE EXTENDED OUTSIDE OF THE HELIX HOUSING AFTER 20 TURNS. THE LEAD WAS SUCCESSFULLY REPLACED AND RETURNED FOR LABORATORY ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413937 INGEVITY IMPLANTABLE LEAD NVN CPI PLANT - ST. PAUL 7740

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR J277| 7741| 7740