D10: concomitant products: ca190rc1, ca190rc1 ablation reusable cable x1, (b)(6) ca20l2, ca20l2 20cm rein percutaneous antenna x1, (lot #s22lg021).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.
|
According to the reporter, during an ablation procedure, temperature alarm activated at the antenna connection, when already positioned in the patient, even after antenna changed and cooling system checked, no effect from reset button. the procedure was cancelled and the patient was already under anesthesia.
|