BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPORE

    MDR report key: 3213568 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10003
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K883602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. ADDITIONAL INFORMATION WAS RECEIVED AND NOTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS DAMAGED DURING PROCEDURE. THE LEAD WAS ABANDONED SURGICALLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312242 BIOPORE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 436-02

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R (B)(4)| 1298| H210| (B)(4)| (B)(4)| 1275| 6949