BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2011-16253

    MDR report key: 2282982 · Received October 7, 2011

    Report

    Report Number
    2124215-2011-16253
    Event Type
    Injury
    Date Received
    October 7, 2011
    Date of Event
    August 31, 2011
    Report Date
    August 31, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. BIFFI M, ZIACCHI M, BERTINI M, GARDINI B, MAZZOTTI A, MASSARO G, MARTIGNANI C, DIEMBERGER I, BORIANI G, CORSINI D. HOW TO TRULY VALUE IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS TECHNOLOGY: UP-FRONT COST OR DAILY COST? INT J TECHNOL ASSESS HEALTH CARE. 2011; 27 (3): 201-6. (B)(6).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A JOURNAL ARTICLE TITLED "HOW TO TRULY VALUE IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS TECHNOLOGY: UP-FRONT COST OR DAILY COST? ". THE STUDY REPORTED ACTUAL ICD LONGEVITY BASED ON THE REAL CLINICAL DATA INSTEAD OF PROJECTIONS OR MODELING, AS IN COST-EFFECTIVENESS ANALYSIS. THE JOURNAL AUTHORS FOLLOWED PATIENTS CONSEQUTIVELY IMPLANTED WITH AN ICD FROM (B)(6) 2009. THE ACTUAL ICD LONGEVITY WAS COMPARED WITH THAT PREDICTED BY MANUFACTURERS TO ASSESS WHETHER THE DEVICE MET EXPECTATIONS OR NOT. OVERALL, 123/153 PATIENTS HAD THEIR DEVICE REPLACED. FROM THE ARTICLE, 43 PATIENTS WITH GUIDANT DEVICES HAD DEVICES REPLACED. ONLY MINI III AND MINI IV SC ICDS AND PRIZM AVT DC ICDS DID NOT MEET PROJECTIONS AMONG GDT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention