BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 6027320 · Received October 13, 2016

    Report

    Report Number
    2124215-2016-15391
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 1, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    PMA / PMN Number
    P010012/S000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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 THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679173 EASYTRAK IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4512

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R 0158| 4470| 4512| 4591| G156| H179| MISMATCH| N119