BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 1635465 · Received March 18, 2010

    Report

    Report Number
    2124215-2010-05885
    Event Type
    Death
    Date Received
    March 18, 2010
    Date of Event
    February 26, 2010
    Report Date
    February 26, 2010
    Manufacturer
    GUIDANT CORPORATION
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE SPECIFIC BOSTON SCIENTIFIC DEVICE INFORMATION INCLUDED IN THIS ARTICLE. THE JOURNAL ARTICLE REFERENCED: GOULD P, KRAHN A (FOR THE CANADIAN HEART RHYTHM SOCIETY WORKING GROUP ON DEVICE ADVISORIES). COMPLICATIONS ASSOCIATED WITH IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR REPLACEMENT IN RESPONSE TO DEVICE ADVISORIES. JAMA 2006: 295:1907-1911. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION IN A JOURNAL ARTICLE OF A STUDY WHERE 17 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTING CENTERS IN CANADA WERE SURVEYED TO ACCESS COMPLICATION RATES AS A RESULT OF GENERATOR REPLACEMENTS DUE TO ICD ADVISORIES FROM 10/04 TO 10/05. THIS SURVEY INCLUDED DEVICES UNDER ADVISORIES FOR (B) (4). THE ARTICLE DISCUSSED THAT THERE WERE 533 PATIENTS WHO HAD ADVISORY ICDS REPLACED. MAJOR COMPLICATIONS OCCURRED IN 43 PATIENTS (8.1%), 10 OF THESE PATIENTS DEVELOPED POCKET INFECTIONS. OUT OF THESE 10 PATIENTS, TWO DEATHS OCCURRED AFTER EXTRACTION; ONE DEATH OCCURRED 24 HOURS AFTER EXTRACTION DUE TO A PERFORATION OF THE RIGHT VENTRICLE AND THE SECOND DEATH OCCURRED A WEEK AFTER THE EXTRACTION PROCEDURE CAUSED BY UNCONTROLLED SEPSIS. THREE ADVISORY-RELATED DEVICE MALFUNCTIONS WERE DETECTED CAUSED BY PREMATURE BATTERY DEPLETION, 2 OF WHICH WERE DETECTED AS A RESULT OF THE ADVISORY. THESE DEVICES WERE SUCCESSFULLY REPLACED WITHOUT CLINICAL CONSEQUENCES. THE MANUFACTURER, MODEL AND SERIAL NUMBERS WERE UNKNOWN WITH EACH OF THESE INCIDENTS. THE ARTICLE ALSO MENTIONED THAT 27 BOSTON SCIENTIFIC DEVICES WERE REPLACED DUE TO AN ADVISORY. NO SPECIFIC MODEL AND SERIAL NUMBERS WERE PROVIDED WITH THIS DATA AND A TOTAL OF 8 DIFFERENT BOSTON SCIENTIFIC DEVICES WERE INCLUDED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE LWS GUIDANT CORPORATION TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R