BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2170401 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09756
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    September 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    --

    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 PROVIDED THAT THIS PATIENT INFECTION WAS NOT RELATED TO THE DEVICE OR LEADS. THE PATIENT HAD A HISTORY OF (B)(6). IT WAS NOTED THAT THE EXTRACTION OF THE SYSTEM WAS UNEVENTFUL. THE PATIENT PASSED AWAY APPROXIMATELY ONE MONTH LATER; HOWEVER, IT WAS CONFIRMED THAT THIS WAS NOT DUE TO THE SYSTEM OR THE EXTRACTION OF THE SYSTEM; BUT WAS DUE TO THE PATIENT BEING VERY ILL.

    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 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 5076| 4512| H135| H219| 0157