BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY

    MDR report key: 6020559 · Received October 12, 2016

    Report

    Report Number
    2124215-2016-14815
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    July 22, 2016
    Report Date
    July 22, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD EXPERIENCED CHEST PAIN A COUPLE DAYS POST IMPLANT. IT WAS NOTED THE PATIENT HAD PERICARDITIS AND ECHOCARDIOGRAPHIC EVALUATION FOUND A SMALL EFFUSION. THE RV LEAD WAS SUSPECTED HAVE PERFORATED, HOWEVER INTERVENTION WAS PERFORMED AND BOTH LEADS WERE REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671472 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7741

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R 7741| 7742| L331