BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3213109 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10639
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 A REVISION PROCEDURE WAS PERFORMED AND ALL PRODUCTS WERE EXTRACTED AS A RESULT OF INFECTION. WHEN CLOSING THE POCKET, THE PATIENT WENT ASYSTOLIC AND CPR WAS PERFORMED. THE PATIENT DID WELL AND A TEMPORARY PACER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312182 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N164

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 4087| H219| 4513| 1823| 0158| N164