BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK CD

    MDR report key: 1982785 · Received February 9, 2011

    Report

    Report Number
    2124215-2011-02428
    Event Type
    Death
    Date Received
    February 9, 2011
    Date of Event
    March 9, 2003
    Report Date
    January 18, 2011
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. 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 PATIENT'S SPOUSE CONTACTED PATIENT SUPPORT ON (B)(6) 2011 TO REPORT THAT THIS DEVICE WAS IMPLANTED ON (B)(6) 2002. THE PATIENT'S SPOUSE INFORMED PATIENT SUPPORT THAT THE PATIENT DIED ON (B)(6) 2003 "DUE TO THE PACEMAKER". THE SPOUSE STATED "THAT IF HE DIDN'T HAVE THIS DEVICE HE WOULD PROBABLY BE ALIVE TODAY". THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT DID NOT FEEL WELL SHORTLY AFTER THE DEVICE WAS IMPLANTED AND CONTINUED TO FEEL ILL UNTIL THE DAY OF HIS DEATH. ACCORDING TO THE PATIENT'S SPOUSE, THE PATIENT DID NOT WANT THE DEVICE IMPLANTED. PATIENT SUPPORT SUGGESTED THAT THE SPOUSE CONTACT THE PHYSICIAN TO DISCUSS THE CAUSE OF DEATH. PATIENT SUPPORT PROVIDED INFORMATION FROM THE BOSTON SCIENTIFIC DEVICE LOOKUP TOOL THAT THE DEVICE IDENTIFIED BY THE MODEL AND SERIAL NUMBER ENTERED IS NOT AFFECTED BY A PRODUCT ADVISORY ISSUED TO PHYSICIANS SINCE (B)(6) 2005. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LOCAL REPRESENTATIVE SPOKE TO THIS PATIENT'S CLINIC. THE PATIENT WAS SEEN BY THE PHYSICIAN ON (B)(6) 2002. THE PHYSICIAN HAD APPARENTLY WRITTEN THAT THE PATIENT STATUS HAD MARKEDLY IMPROVED INCLUDING REDUCTION IN REGARDS TO HIS DYSPNEA, HOWEVER THE PHYSICIAN STATED THAT THE PATIENT CONTINUED TO BE UNACCEPTABLY OVERWEIGHT AND SEDENTARY. THE PATIENT WAS SCHEDULED TO RETURN FOR EVALUATION ON (B)(6) 2003, HOWEVER, THE APPOINTMENT WAS CANCELLED. NO ADDITIONAL INFORMATION IS AVAILABLE CONCERNING THE EVENTS ON THE DATE OF DEATH AND THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK CD IMPLANTABLE CHF GENERATOR NIK CPI PLANT - ST. PAUL 1823

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death 0154| 1823| 4512| 4470