BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2173727 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-12292
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 18, 2011
    Report Date
    August 5, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMAITON AND WERE UNSUCCESSFUL. ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCT REMAINS IN SERVICE. 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED TO A VALUE OTHER THAN MONITOR PLUS THERAPY. IT WAS UNKNOWN IF THE PROGRAMMING WAS INTENTIONAL AND ORDERED BY THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    OUR COMPANY RECEIVED ADDITIONAL INFORMATION SEVEN WEEKS LATER FROM THE FIELD REPRESENTATIVE THAT THE PHYSICIAN HAD ORDERED THE DEVICE THERAPY TO BE PROGRAMMED OFF AS THE PATIENT WAS IN HOSPICE WITH PANCREATIC CANCER. A REVIEW OF OUR RECORDS FOUND THAT THE PATIENT PASSED AWAY. THERE WERE NO ALLEGATIONS OR EVIDENCE TO SUGGEST THAT A MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H215

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR H215| 1170| 1130| 0158| 4269| 4512| H175