BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1864984 · Received October 12, 2010

    Report

    Report Number
    2124215-2010-16989
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THAT THE PHYSICIAN WAS AWARE AND PLANNED TO BRING THE PATIENT IN FOR DEFIBRILLATION THRESHOLD TESTING (DFT). NO ADDITIONAL INTERVENTION OR TROUBLESHOOTING HAS BEEN PERFORMED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXHIBITING A LOW OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENT LESS THAN 20 OHMS. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT REVIEWED THE MOST RECENT LEAD DATA WHICH INDICATED THE SHOCKING IMPEDANCES WERE IN RANGE AT 58 AND 52 OHMS THE FOLLOWING TWO DAYS. THE SHOCK IMPEDANCE HAS BEEN STABLE SINCE IMPLANT AND HISTORICALLY RANGES BETWEEN THE LOW 50'S TO THE LOW 60'S. RECOMMENDATIONS WERE MADE TO TRY TO RECREATE THE LOW IMPEDANCE READING BY PERFORMING ISOMETRICS AND POCKET MANIOULATION. IT WAS ALSO DISCUSSD THAT A MAX ENERGY SHOCK COULD BE DELIVERED TO TEST THE INTEGRITY OF THE SYSTEM. THE LAST DELIVERED SHOCK WAS AT IMPLANT WHICH HAD A NORMAL IMPEDANCE OF 47 OHMS. THE LOCAL AREA SALES REPRESENTATIVE PLANNED TO DISCUSS THE AVAILABLE OPTIONS WITH THE PHYSICIAN.

    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 67 YR E110| MISMATCH| 0157| 1488T| 1861