BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 4220969 · Received November 3, 2014

    Report

    Report Number
    2124215-2014-16597
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THIS SYSTEM HAS BEEN EXPLANTED DUE TO INFECTION. THERE WERE BACTERIUM CONFIRMED VIA CULTURES. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703304 EASYTRAK IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4511

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R 5524M| 4511| MISMATCH| N141| 1581| H179| 5092| 4137