BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3211046 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08179
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 DURING THE IMPLANT PROCEDURE FOR THIS SYSTEM, AFTER THE LEADS WERE IMPLANTED AND INSERTED INTO THE DEVICE, THE PATIENT'S BLOOD PRESSURE DROPPED. A THORACOTOMY WAS PERFORMED AND BLOOD WAS SEEN. A PERICARDIOSCENTESIS WAS THEN PERFORMED. EVENTUALLY A STERNOTOMY WAS PERFORMED WHERE BLOOD WAS SUCTIONED OUT. A BALLOON PUMP WAS INSERTED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR RECOVERY. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THE PATIENT HAD RECOVERED FROM THE PROCEDURE WITH NO FURTHER ISSUES. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310722 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E163

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R MISMATCH| 0185| E163