BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPLANTABLE CHF GENERATOR

    MDR report key: 2603738 · Received June 7, 2012

    Report

    Report Number
    2124215-2012-08093
    Event Type
    Death
    Date Received
    June 7, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 21, 2012
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE ARTICLE AUTHOR(S) WERE UNSUCCESSFUL. THE FINDINGS OF THE STUDY WERE SUMMARIZED IN THE ARTICLE: DE BIE MK, VAN REES JB, THIJSSEN J, BORLEFFS CJW, TRINES SA, CANNEGIETER SC, SCHALIJ MJ, VAN ERVEN L. CARDIAC DEVICE INFECTIONS ARE ASSOCIATED WITH A SIGNIFICANT MORTALITY RISK. HEART RHYTHM. 2012; 9 (4): 494-8.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A JOURNAL ARTICLE REVIEW. THE STUDY WAS COMPLETED TO ASSESS THE PROGNOSTIC IMPORTANCE OF CARDIAC DEVICE INFECTION (CDI) IN PATIENTS WHO HAVE RECEIVED (B)(4) AND (B)(4). THE PATIENTS IMPLANT DATES WERE ALL BETWEEN (B)(6) 2000 AND (B)(6) 2009. THE PROGNOSTIC IMPORTANCE OF THE FIRST CDI ON MORTALITY WAS ASSESSED BY MODELING CDI AS A TIME-DEPENDENT COVARIATE IN THE COX PROPORTIONAL HAZARDS MODEL WHICH DETERMINED THAT FOR PATIENTS PRESENTING WITH CDI, THE RISK OF DEATH WAS 1.9 TIMES HIGHER THAN THAT FOR PATIENTS WHO REMAINED FREE OF CDI. (B)(4). REPORTED ADVERSE PATIENT EFFECTS INCLUDED: DEATH, ENDOCARDITIS (WITH OR WITHOUT VEGETATION), INFECTION AT THE GENERAL POCKET SITE, PERSISTENT FEVER, POSITIVE BLOOD CULTURE, BACTEREMIA, MULTIPLE INFECTIONS, SWELLING, PAIN, WARMTH, SKIN DISCOLORATION, RELAPSE OF CDI (ONE DEATH OCCURRED AFTER TWO IMPLANT PROCEDURES HAD OCCURRED; THE ORIGINAL DEVICE WAS REMOVED AND REPLACED DUE TO CDI WHICH THEN RECURRED AND RESULTED IN SEPTIC SHOCK AND SUBSEQUENT DEATH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE CHF GENERATOR NIK GUIDANT PUERTO RICO BV HEART FAILURE DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R