BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 4132342 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15025
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    June 5, 2014
    Report Date
    July 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    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 THE COMPLETE LEAD WITH STYLET STILL INSERTED WAS RETURNED AND EVALUATED. THE HELIX WAS PARTIALLY EXTENDED WITH DRIED BLOOD/BODY FLUID IN THE HELIX HOUSING AND NECK REGION. X-RAY SHOWED THE INNER CONDUCTOR COIL WAS FRACTURED AT THE DISTAL END OF THE TERMINAL PIN. THE ETFE SLEEVE WAS TORN APART WITH A CLOCKWISE TWIST AT THE SITE OF FRACTURE. ANALYSIS CONCLUDED THE FRACTURE MOST LIKELY RESULTED FROM TORSION OVERLOAD WHILE EXTENDING THE HELIX. THE LEAD DESIGN COUPLED WITH PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE INABILITY TO EXTEND THE HELIX AND SUBSEQUENT FRACTURE. NO DAMAGE WAS NOTED AT THE LEAD TIP THAT WOULD HAVE CONTRIBUTED TO THE REPORTED DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS AN ATTEMPTED RIGHT VENTRICULAR (RV) IMPLANT. ROTATING NO MORE THAN 10 TURNS SLIGHTLY FASTER THAN ONE ROTATION PER SECOND, THE LEAD HELIX WAS NOTED TO NOT EXTEND INTO THE TISSUE WHEN USING THE PROVIDED FIXATION TOOL CAUSING THE LEAD TO DISLODGE PRIOR TO POCKET CLOSURE. THE PHYSICIAN EXTRACTED AND REPLACED THE LEAD WITHOUT CONSEQUENCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD WAS NEVER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612228 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7742

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 7741| 7742| J067