BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY

    MDR report key: 4140406 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17310
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOLLOWING IMPLANT OF THIS RIGHT ATRIAL (RA) LEAD THE PATIENT COMPLAINED OF CHEST PAIN. AN ECHOCARDIOGRAM CONFIRMED A SMALL PERICARDIAL EFFUSION. A REPEAT ECHOCARDIOGRAM TWO WEEKS LATER NOTED THAT THE PERICARDIAL EFFUSION HAD INCREASED IN SIZE. THERE WERE CONCERNS THAT THE LEAD HAD PERFORATED THE PATIENT¿S HEART WALL. THE PATIENT UNDERWENT CARDIAC SURGERY BUT A PERFORATION COULD NOT BE CONFIRMED. THE LEAD WAS EXPLANTED AND REPLACED WITH AN EPICARDIAL LEAD. THE LEAD WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619102 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7741

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R MISMATCH| 7742| 7741