BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IROX

    MDR report key: 2052913 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04311
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABANDONED LEAD HAS NOT BEEN RETURNED FOR ANALYSIS THEREFORE BOSTON SCIENTIFIC CANNOT CONFIRM THIS CLINICAL OBSERVATION. 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 VENTRICULAR LEAD WAS ABANDONED SURGICALLY DUE TO LOSS OF SENSING AND CAPTURE. THE IMPEDANCE MEASUREMENT WAS GREATER THAN 2000 OHMS. A LEAD REPLACEMENT WAS ATTEMPTED HOWEVER ACCESS COULD NOT BE GAINED DUE TO THE PATIENT'S ANATOMY. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER LEAD IN THE FUTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)| 4137| S603| 1298