BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2180977 · Received July 27, 2011

    Report

    Report Number
    2124215-2011-12700
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 AN LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PRESENTED TO THE EMERGENCY ROOM WITH REPORTS OF SHOCK DELIVERY AND OF UNSPECIFIED SYMPTOMS. A REVIEW OF THE STORED EPISODE IDENTIFIED POSSIBLE VENTRICULAR FIBRILLATION (VF) ASSOCIATED WITH LOW AMPLITUDE SIGNALS. THERE WAS EVIDENCE OF UNDERSENSING OF UNKNOWN DURATION ASSOCIATED WITH INAPPROPRIATE PACING OUTPUT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED REPROGRAMMING OF THE DEVICE VENTRICULAR SENSITIVITY SETTING. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE REPORTED THAT THE ARRHYTHMIA WAS TERMINATED WITH NO IRREPARABLE INJURY OR COMPLICATIONS TO THE PATIENT. THERE HAS BEEN NO FURTHER VENTRICULAR FIBRILLATION (VF) EPISODES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R 4542| 0185| 1810| T125| 4087| N119| 4269| 0125