BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY

    MDR report key: 4132347 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14206
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    August 12, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD WAS PERFORMED. INSPECTION OF THE LEAD BODY FOUND NO ANOMALIES. THE HELIX WAS EXTENDED, WITH DRIED BODY TISSUE ENTWINED IN THE HELIX AND DRIED BLOOD WITHIN THE HELIX MECHANISM. THE LEAD WAS PLACED IN AN ULTRA-SONIC CLEANER FOR 60 MINUTES, TO REMOVE THE DRIED BLOOD AND TISSUE; HOWEVER, THE HELIX MECHANISM REMAINED STUCK. ELECTRICAL TESTING WAS PERFORMED AND THE LEAD WAS CONFIRMED TO BE ELECTRICALLY CONTINUOUS, AND AN X-RAY OF THE CONDUCTOR COIL FOUND NO ANOMALIES. THE CAUSE OF THE STUCK HELIX COULD NOT BE DETERMINED. LABORATORY TESTING DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE RESULTED IN THE CLINICAL OBSERVATIONS OF DISLODGEMENT AND DIAPHRAGMATIC STIMULATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS RIGHT ATRIAL (RA) LEAD COMPLAINED OF PHRENIC NERVE STIMULATION. IT WAS DETERMINED THAT THE RA LEAD HAD DISLODGED AND WAS NOW IN THE PATIENT'S SUPERIOR VENA CAVA. ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL AS THE HELIX MECHANISM WAS STUCK. THE LEAD WAS EXPLANTED AND REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612949 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7741

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 7741