BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3210929 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08866
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DELIVERED FIVE SHOCKS TO THE PATIENT WHERE IN THE FIRST SHOCK THE PATIENT FELL DOWN AND WOKE UP IN THE HOSPITAL. THE PATIENT STATED THEY WERE WALKING UP THE STAIRS WHEN THE FIRST SHOCK CAME, AND IN THE SHOWER WHEN THEY RECEIVED FOUR MORE SHOCKS. ATTEMPTS TO GAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE DEVICE REMAINS IMPLANTED AT THIS TIME. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312114 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E162

    Patients

    Seq Age Sex Outcome Treatment
    1 274 MO Hospitalization| L| R 0292| E162| 4135