BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY

    MDR report key: 6023732 · Received October 12, 2016

    Report

    Report Number
    2124215-2016-15742
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 5, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INGEVITY LEAD WAS RETURNED TO BOSTON SCIENTIFIC¿S POST MARKET QUALITY ASSURANCE LABORATORY WITH THE HELIX MECHANISM IN A RETRACTED POSITION. VISUAL INSPECTION FOUND DRIED BLOOD AROUND THE HELIX. SUBSEQUENT ELECTRICAL AND MECHANICAL TESTING DID NOT IDENTIFY ANY PRODUCT ABNORMALITIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. LABORATORY ANALYSIS WAS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED HELIX EXTENSION/RETRACTION PROBLEMS. SEVERAL IMPLANT TECHNIQUE AND PRODUCT DESIGN FACTORS MAY CONTRIBUTE TO HELIX EXTENSION/RETRACTION DIFFICULTIES, INCLUDING: TORTUOUS PATIENT ANATOMY OR BENDS IN THE PROXIMAL PORTION OF THE LEAD REMAINING OUTSIDE OF THE BODY, SHARP BENDS IN THE STYLET, KINKS IN THE LEAD INTRODUCER SHEATH, UNDER-ROTATING OR OVER-ROTATING THE TERMINAL TOOL, FAILURE TO REMOVE THE TERMINAL TOOL BETWEEN EXTENSION/RETRACTION CYCLES TO RELEASE TORQUE STORED IN THE INNER COIL, EXCESSIVELY FAST TOOL ROTATION SPEED (>1 FULL TURN PER SECOND), AND THE PRESENCE OF TISSUE IN THE HELIX, WHICH MAY ACCUMULATE WITH MULTIPLE LEAD REPOSITIONING ATTEMPTS. IN ADDITION, THE INGEVITY LEAD WAS DESIGNED WITH SINGLE FILAR INNER AND OUTER COILS FOR IMPROVED FLEX FATIGUE AND FOR BETTER PERFORMANCE WITHIN AN MRI ENVIRONMENT, WITH MULTIPLE LAYERS OF INSULATION BETWEEN THE CONDUCTORS FOR LONG-TERM RELIABILITY. THIS DESIGN, IN CONJUNCTION WITH THE CONTRIBUTING FACTORS MENTIONED ABOVE, MAY IMPACT THE RATE AT WHICH TORQUE IS TRANSFERRED FROM THE TERMINAL PIN TO THE HELIX MECHANISM. APPROVED INSTRUCTIONS FOR USE PROVIDE BEST PRACTICES TO MITIGATE THESE POTENTIAL CONTRIBUTING FACTORS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISLODGED. AN INVASIVE PROCEDURE WAS PERFORMED TO REPOSITION THE LEAD. DIFFICULTY WAS EXPERIENCED RETRACTING THE HELIX MECHANISM. THE LEAD WAS REMOVED AND TISSUE WAS NOTED ON THE LEAD TIP. AN ATTEMPT TO REMOVE THE TISSUE WAS MADE, HOWEVER THE HELIX STILL COULD NOT BE RETRACTED. A DIFFERENT LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672349 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7740

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| L| R 0293| 4135| 7740| E142