Product event summary: the 990063-020 mapping catheter with lot number 228074049 was returned and analyzed.Visual inspection of the shaft segment area showed the shaft was kinked approximately 2.7 inches from the lemo connector.The functional test was performed and the continuity and impedance measurement between the electrodes and the other side of the cable showed the electrode's continuity and impedance to the cable were normal.In conclusion, the mapping catheter failed the returned product inspection due to a shaft kink.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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