BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 1850194 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-13849
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 2, 2010
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE PATIENT EFFECTS HAVE BEEN OBSERVED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD WAS EXPLANTED DUE TO A PATIENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL CPI ST. PAUL 0056

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 1705| 0048| 6836| MISMATCH| 0056| 1746| 1796| 0074