BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 3211362 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08912
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    November 26, 2012
    Report Date
    May 9, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 THIS PATIENT ADVOCATE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) IN (B)(6) 2013 TO REPORT THAT THIS PATIENT HAD BEEN DIAGNOSED WITH ENDOCARDITIS IN (B)(6) 2012. ACCORDING TO THE PATIENT ADVOCATE, THE DEVICE WAS EXPLANTED IN (B)(6) 2012 AND THE PATIENT DIED IN (B)(6) 2013. THERE WAS NO SPECIFIC COMPLAINT THAT THE IMPLANTED SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE. ACCORDING TO THE DEATH SUMMARY REPORT, THE CAUSE OF DEATH WAS ATTRIBUTED TO RECURRENT HEART FAILURE AND MALNUTRITION. THE PATIENT'S HOSPITAL COURSE WAS COMPLICATED BY A GI BLEED, DELIRIUM, SEVERE MALNUTRITION (DESPITE FEEDING TUBE PLACEMENT) AND EVENTUAL PULSELESS ELECTRICAL ACTIVITY (PEA) RESULTING IN ANOXIC BRAIN INJURY. THE LOCAL REPRESENTATIVE CONFIRMED THAT THE DEVICE HAD BEEN EXPLANTED IN (B)(6) 2012 WITH RETENTION OF THE EPICARDIAL LEAD. THE INFECTIOUS PHYSICIAN'S NOTE INDICATED THAT THE PATIENT HAD BEEN ADMITTED FOR SURGICAL INTERVENTION DUE TO (B)(6) BACTEREMIA (OUTSIDE HOSPITAL CULTURES) AND DEVICE-ASSOCIATED (B)(6). THERE WAS NO INFORMATION THAT REPORTED THAT THE IMPLANTED SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. A REPLACEMENT DEVICE WAS NOT IMPLANTED PRIOR TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311596 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H220

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 0158| 4968| H220| H170| 4087