BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3953806 · Received July 23, 2014

    Report

    Report Number
    2124215-2014-13966
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 WAS SCHEDULED TO BE PART OF A SYSTEM REVISION DUE TO INFECTION. ADDITIONAL INFORMATION WAS ATTEMPTED HOWEVER; THERE WAS NO CONFIRMATION THAT THE SYSTEM WAS EXPLANTED. NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT STATUS REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431957 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E162

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening N119| E162| 1688TC| 0292| 1058T| 1581| MISMATCH