BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVENE

    MDR report key: 2283092 · Received October 7, 2011

    Report

    Report Number
    2124215-2011-15086
    Event Type
    Injury
    Date Received
    October 7, 2011
    Date of Event
    August 26, 2011
    Report Date
    September 13, 2011
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A LEAD REVISION PROCEDURE WILL BE SCHEDULED FOR A LATER DATE. RECORDS INDICATE THIS LEAD REMAINS IN SERVICE. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    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 INDICATING AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS CAPPED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERVENE IMPLANTABLE LEAD NVY GUIDANT ANGLETON/ST. PAUL 497-20

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| 1860| 5076| (B)(4)| (B)(4)| E102