BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTRA

    MDR report key: 2041577 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01058
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K822357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 RIGHT ATRIAL (RA) LEAD WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION ASSOCIATED WITH THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention 4270| 1297| 4260