BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1871840 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17607
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 29, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE AND LEAD REMAINS IN-SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT'S LATITUDE SYSTEM DETECTED A RED ALERT (LOW SHOCK IMPEDANCE). THE LOCAL REPRESENTATIVE AND PHYSICIAN WERE CONTACTED AND NOTIFIED OF THE ALERT. SUBSEQUENTLY, BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE LATITUDE RED ALERT. TECHNICAL SERVICES REVIEWED DATA FROM LATITUDE AND INFORMED THE LOCAL REPRESENTATIVE THAT THE SHOCK IMPEDANCE MEASUREMENTS HAD BEEN STABLE (MID TO HIGH 30 OHM RANGE). HOWEVER, IN THE LAST MONTH, THERE HAD BEEN TWO OR THREE MEASUREMENTS THAT WERE LESS THAN 20 OHMS. TECHNICAL SERVICES DISCUSSED THE POSSIBILITY THAT A DELIVERED SHOCK INTO A SHORTED LEAD CONDITION MAY DAMAGE THE DEVICE. THE LOCAL REPRESENTATIVE REPORTED THAT THE PATIENT WAS CURRENTLY IN ATRIAL FIBRILLATION (AF) AND WAS PLACED ON COUMADIN. CONSEQUENTLY, THE LEAD COULD NOT BE TESTED BY DELIVERY OF A TEST SHOCK. TECHNICAL SERVICES DISCUSSED THE POSSIBILITY THAT A CHEST XRAY MAY REVEAL AN ABNORMALITY. SUBSEQUENTLY, BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM THE CLINIC NURSE THAT THIS PATIENT HAS AN INFECTION. THE DEVICE AND LEAD SYSTEM WILL BE REPLACED ONCE THE INFECTION RESOLVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L H210| H170| 0158| 4470| 4537