BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 3052572 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03744
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 25, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS ANALYZED UPON RECEIPT AT THE POST MARKET QUALITY ASSURANCE LAB. ANALYSIS OF THE DEVICE MEMORY CONFIRMED THERAPY WAS AVAILABLE AT THE TIME OF EXPLANT AND SHOWED THE DEVICE DID NOT REACH ERI PRIOR TO EXPLANT. THE LONGEVITY WAS CALCULATED FOR THIS DEVICE WHICH SHOWED IT WAS DEPLETING NORMALLY. DAMAGE OBSERVED ON THE DEVICE WAS DETEREMINED TO BE INDUCED FROM THE EXTERNAL SHOCK THE PATIENT RECEIVED PRIOR TO THE EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT THE POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY CONFIRMED THERAPY WAS AVAILABLE AT THE TIME OF EXPLANT AND THE DEVICE DID NOT REACH ERI PRIOR TO THE EXPLANT PROCEDURE. FURTHER ANALYSIS CONFIRMED THIS DEVICE WAS DEPLETING NORMALLY. THERAPY AVAILABILITY TESTING COULD NOT BE PERFORMED DUE TO THE INDUCED DAMAGE TO THE DEVICE AS A RESULT OF THE EXTERNAL SHOCK APPLIED IN THE FIELD TO CONVERT THE PATIENT.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THIS DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THIS DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT AND A FINAL REPORT WILL BE SENT FOLLOWING LABORATORY TESTING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE HOSPITAL RECENTLY LOCATED THIS DEVICE. THE DEVICE HAS BEEN SHIPPED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE AND RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) COMPETITOR LEADS, WENT INTO ATRIAL FIBRILLATION (AF) AND SUBSEQUENTLY HAD TO RECEIVE AN EXTERNAL SHOCK. THE PATIENT WAS ADMITTED TO THE HOSPITAL WERE THE DEVICE AND LEAD MEASUREMENTS WERE TESTED. TESTS REVEALED THE DEVICE AND LEADS HAD LOW SHOCK IMPEDANCE LESS THAN 20 OHMS AND LOW PACING IMPEDANCES LESS THAN 200 OHMS. THE DECISION WAS MADE TO PERFORM A REVISION PROCEDURE. THE DEVICE, RA AND RV COMPETITOR LEADS WERE EXPLANTED. THE DEVICE WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154255 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H240

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R