BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IROX

    MDR report key: 2913658 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17169
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 21, 2012
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE AND THIS PRODUCT WAS SURGICALLY CAPPED AND ABANDONED. IT WAS REPORTED THAT UPON DISCONNECTING THIS LEAD THE PHYSICIAN NOTED THAT THE LEAD TERMINAL WAS DISSEMBLED, SUCH THAT THE TERMINAL PIN/TIP WAS SEPARATED FROM THE SILICONE BOOT OF THE LEAD. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING IMPEDANCES FROM 200-240 OHMS ALONG WITH POCKET STIMULATION, NOISE AND POOR DECREASED SENSING. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. THE PATIENT WAS TO BE REFERRED FOR A LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21596 IROX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 430-07

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Hospitalization| L| R (B)(4)| (B)(4)| S401| 1194