BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3211026 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07975
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A VENTRICULAR TACHYCARDIA (VT) EPISODE FOR WHICH THE DEVICE DELIVERED ANTI-TACHYCARDIA PACING (ATP). THE ATP ACCELERATED THE RHYTHM INTO THE VENTRICULAR FIBRILLATION (VF) ZONE WHERE SHOCK THERAPY WAS DELIVERED AND SUCCESSFULLY CONVERTED THE RHYTHM. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYNCOPAL EPISODE AS A RESULT OF THE VF AND FELL AND SUSTAINED A HEAD INJURY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS ADMITTED TO THE HOSPITAL FOR OVERNIGHT MONITORING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311400 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E162

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L 4469| 0295| E162