BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1954122 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24371
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 10, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEW INFORMATION WAS RECEIVED INDICATING THE PATIENT WAS SEEN FOR A NORMAL FOLLOW-UP APPOINTMENT AND SHOCK IMPEDANCE MEASUREMENTS HAD INCREASED TO 114 OHMS FROM A STEADY 88 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE VALUES WERE STILL WITHIN RANGE, PARTICULARLY WITH THIS SINGLE COIL LEAD, HOWEVER DISCUSSED HOW THE CHANGE IS RELATIVELY HIGH PERCENT SO RECOMMENDED MONITORING TO SEE IF THE VALUES INCREASE ANY FURTHER. ALL OTHER LEAD DIAGNOSTICS WERE NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE INDIACTING THIS TO BE A DEVICE ISSUE AND NOT A LEAD ISSUE.

    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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT WAS DETECTED DUE TO HIGH SHOCK IMPEDANCES THAT WERE GREATER THAN 125 OHMS. IMPEDANCES WERE WITHIN NORMAL RANGE AND STARTED TO INCREASE OVER THE LAST COUPLE MONTHS. THE SALES REPRESENTATIVE NOTED THEY DID A COMMANDED TEST SINCE THEY HAD THE RED ALERT. AT 1.1 J SHOCK, IMPEDANCES WERE 80 OHMS AND AT 31 J SHOCK, IMPEDANCES WERE 78 OHMS. BASED ON THIS TESTING, THE PHYSICIAN FELT COMFORTABLE WITH THE INTEGRITY OF THE LEAD AND ELECTED TO MONITOR THE PERFORMANCE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR E102| 0180