BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 2780995 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13317
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 29, 2012
    Report Date
    September 29, 2012
    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 PRODUCT PRESENTED TO THE HOSPITAL AFTER RECEIVING APPROPRIATE SHOCK THERAPY. A POCKET INFECTION WAS OBSERVED AND THE PATIENT WAS HOSPITALIZED FOR A SYSTEM REVISION. THE SYSTEM WAS NOT REPLACED AS OF THIS DATE. THE PATIENT WITH THIS DEVICE HAS A CONFIRMED (B)(6) INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E163

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R