BEUDAMED
    FDA Adverse Event Death Summary report: N

    2124215-2011-04011

    MDR report key: 2008695 · Received March 7, 2011

    Report

    Report Number
    2124215-2011-04011
    Event Type
    Death
    Date Received
    March 7, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS MADE TO OBTAIN THE SPECIFIC DEVICE INFORMATION FOR THE REPORTED COMPLICATIONS AND DEATHS HAVE BEEN UNSUCCESSFUL. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. REFERENCE: ALZUETA J, LINDE A, BARRERA A, PENA J, PEINADO R. SPANISH IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR REGISTRY. SIXTH OFFICIAL REPORT OF THE SPANISH SOCIETY OF CARDIOLOGY WORKING GROUP ON IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS (2009). REV ESP CARDIOL. 2010; 63(12): (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THROUGH A JOURNAL ARTICLE OF A STUDY LOOKING AT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) OVER A PERIOD OF TIME. THE DEVICES USED IN THIS STUDY WERE FROM VARIOUS MANUFACTURERS, INCLUDING BOSTON SCIENTIFIC. IN TOTAL, 4108 DEVICE IMPLANTATIONS WERE REPORTED, WHICH COMPRISED 88.6% OF THE ESTIMATED TOTAL NUMBER OF IMPLANTATIONS CARRIED OUT. FIVE OF THE PATIENTS DIED DURING IMPLANTATION. IN ADDITION, 18 COMPLICATIONS DURING IMPLANTATION WERE REPORTED: 1 CASE OF TAMPONADE, 4 OF PNEUMOTHORAX AND 13 UNSPECIFIED. THE MANUFACTURER, MODEL AND SERIAL INFORMATION FOR THE DEVICE INVOLVED WAS NOT PROVIDED.

    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 Death