BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 2910673 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16087
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 12, 2012
    Report Date
    December 3, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE FIELD REPRESENTATIVE WAS UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION FROM THE CLINIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT'S DAUGHTER-IN-LAW CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DUE TO CONCERNS OVER THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAVING TO BE EXPLANTED APPROXIMATELY TWO YEARS AFTER IMPLANT. THE PATIENT ADVOCATE WAS UNCERTAIN AS TO THE REASON FOR EXPLANT AND EXPRESSED GENERAL FRUSTRATION WITH THE PATIENT'S PHYSICIAN. THE FIELD REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION RELATING TO THIS EVENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18923 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR NKE GUIDANT CRM CLONMEL IRELAND H125

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4136| H125| 4517| 4135