BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2162579 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07091
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 21, 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

    THE REPRESENTATIVE FURTHER DISCUSSED TROUBLESHOOTING WITH THE PHYSICIAN. THE PHYSICIAN OPTED NOT TO DO A POCKET REVISION. THE DEVICE WAS PROGRAMMED TO RV COIL TO CAN WITH NO FURTHER DEFIBRILLATION TESTING IN THIS CONFIGURATION.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS REMAIN IN SERVICE. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE DEFIBRILLATION THRESHOLD TESTING (DFT) OF THIS NEWLY IMPLANTED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PATIENT REQUIRED 41 JOULES TO CONVERT. THE PATIENT WAS REPORTED TO BE VERY SICK WITH AN EJECTION FRACTURE OF AROUND 10%. THE PATIENT DEVELOPED FLUTTER DURING DFT WHICH REQUIRED PHARMACOLOGICAL INTERVENTION. IN ADDITION, DUE TO THE PATIENT'S LARGE ATRIUM THERE WAS DIFFICULTY GETTING THE RIGHT VENTRICULAR LEAD PASS THE TRICUSPID VALVE. IN ADDITION, THE SHOCK IMPEDANCE WAS REPORTED TO BE GREATER THAN 125 OHMS PRIOR TO THE PATIENT'S DISCHARGE WHILE IN TRIAD CONFIGURATION AND IN COLD CAN. HOWEVER, WHILE IN THE RV COIL TO CAN CONFIGURATION IT WAS 73 OHMS. THERE WAS SUSPECT OF A LOOSE PROXIMAL SET SCREW. TECHNICAL SERVICES INQUIRED OF PATIENT STATUS AND RESOLUTION.

    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