BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 2905473 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13475
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO THE HOSPITAL PATHOLOGY LAB AND MAY NOT BE RETURNED FOR ANALYSIS. HOWEVER, IF THE DEVICE IS RETURNED, ANALYSIS WILL BE PERFORMED TO DETERMINE IF THE DEVICE DID OR DID NOT DEPLETE PREMATURELY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO HIGH OUTPUTS, ALONG WITH CONCERN FOR A POSSIBLE OUT OF SPECIFICATION CONDITION THAT RESULTED IN PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10658 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H229

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R 4513| H179| 0158| 4469| H229| H135| N164