BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 4131449 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-13677
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    May 14, 2014
    Report Date
    July 7, 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 WAS RETURNED AND EVALUATED. THE LEAD WAS RETURNED WITH THE STYLET STILL INSERTED EXTENDING BEYOND THE TERMINAL PIN END. THE STYLET AND LEAD WERE NOTED TO BE BENT AND CURVED IN SEVERAL PLACES, ONE OF WHICH WAS NEAR THE LEAD TIP. THE HELIX WAS RETRACTED WITH DRIED BLOOD/BODY FLUID IN THE HELIX HOUSING AND NECK REGION. THE LEAD DID NOT PASS CONTINUITY TESTING; X-RAY SHOWED THE INNER CONDUCTOR COIL WAS FRACTURED AT THE DISTAL END OF THE TERMINAL PIN. X-RAY OF THE LEAD TIP SHOWED NO ANOMALIES. BASED ON THE APPEARANCE OF THE INNER COIL AT THE TERMINAL END, ANALYSIS CONCLUDED THE FRACTURE MOST LIKELY RESULTED WHEN ATTEMPTING TO EXTEND THE HELIX. THE LEAD DESIGN COUPLED WITH PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE INABILITY TO EXTEND THE HELIX AND SUBSEQUENT FRACTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS AN ATTEMPTED RIGHT VENTRICULAR (RV) IMPLANT. WHEN ATTEMPTING TO REPOSITION THE LEAD FOLLOWING DISLODGEMENT THE HELIX COULD NO LONGER BE MANIPULATED AFTER SEVERAL EXTENSION AND RETRACTION SEVERAL TIMES. THE LEAD WAS EXTRACTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD WAS NEVER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610457 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7741

    Patients

    Seq Age Sex Outcome Treatment
    1