ISOLINE

Description of Event or Problem

REPORTEDLY, AN INCREASE OF THE RIGHT ATRIAL AND RIGHT VENTRICULAIRE IMPEDANCE AND THRESHOLD VALUES. OVERSENSING WAS ALSO OBSERVED AND RECORDED ON THE ATRIAL AND VENTRICULAR EGM. THE SERIAL NUMBERS, MODEL OF THE LEADS, THE DATES OF IMPLANTATION ARE UNKNOWN. NO MORE INFORMATION ARE AVAILABLE.

Additional Manufacturer Narrative

AS NO INFORMATION WAS PROVIDED AND AS THE SERIAL NUMBER OF THE LEAD IS UNKNOWN AND THE LEAD IS NOT RETURNED TO BE ANALYSIS, NO CONCLUSION COULD BE ESTABLISHED. THE EVENT IS RECOVERED IN OUR DATABASE FOR TRENDS PURPOSES. PLEASE FIND ENCLOSED THE REPORT RECEIVED FROM THE FDA. PLEASE FIND ENCLOSED THE REPORTS RECEIVED FROM THE FDA.