BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2040052 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00780
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 4, 2011
    Report Date
    July 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE HIGH RIGHT ATRIAL (RA) LEAD IMPEDANCES HAD STABILIZED. THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCES WERE ELEVATED; HOWEVER, WERE NOT OUT OF RANGE AND NOISE WAS NOTED ON THE RV CHANNEL. IT WAS QUESTIONED IF THIS COULD BE A LOOSENED HEADER. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE BEHAVIOR OF A LOOSENED HEADER. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE ELEVATED IMPEDANCES COULD NOT BE REPRODUCED. IT WAS NOTED THAT THE PATIENT'S LEFT SIDED VASCULATURE WAS TOTALLY OCCLUDED, THUS THE PHYSICIAN CHOSE TO IMPLANT A NEW SYSTEM ON THE RIGHT SIDE. THIS DEVICE AND THE NON-BOSTON SCIENTIFIC LEADS WERE LEFT IN PLACE WITH ALL THERAPIES OFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED VARIABLE ATRIAL AND RIGHT VENTRICULAR (RV) IMPEDANCES, EXHIBITED BY NON-BOSTON SCIENTIFIC LEADS. IT WAS NOTED THAT THE MEASUREMENTS WERE INTERMITTENTLY GREATER THAN 2,000 OHMS. A SAVE TO DISK WAS PERFORMED AND WILL BE RETURNED FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention E110| MISMATCH