BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTRA

    MDR report key: 3240119 · Received July 22, 2013

    Report

    Report Number
    2124215-2013-10505
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 25, 2013
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT HAD A CHRONIC ENDOCARDITIS. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. ALL AVAILABLE INFORMATION INDICATES HE PRODUCT WAS SURGICALLY ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339553 SENTRA IMPLANTABLE LEAD DTB HISTORICAL CPI ST. PAUL 4270

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R 4270| 1130| 4260| 0940| MISMATCH