BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2051781 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03668
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    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 THE PATIENT WAS NOT BROUGHT INTO THE CLINIC FOR FURTHER TROUBLESHOOTING. THE DATE THAT THE LOW SHOCK IMPEDANCE OCCURRED THE PATIENT WAS HAVING AN ABLATION PROCEDURE AND THE PHYSICIAN FELT IT WAS RELATED TO THE PROCEDURE. AT THIS TIME THERE WERE NO PLANS FOR INTERVENTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA LATITUDE REMOTE MONITORING THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED A LOW SHOCK IMPEDANCE MEASUREMENT LESS THAN 20 OHMS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT ADVISED BRINGING THE PATIENT IN FOR ADDITIONAL TROUBLESHOOTING. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    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 65 YR (B)(4)| (B)(4)| MISMATCH