BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1946208 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20740
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Removal / Correction Number
    Z-875/897-03
    Adverse Event
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening| R 4271| 4285| 4088| 4087| 1298| (B)(4)| S601| 1273