It was reported that the patient presented to the emergency department for shortness of breath, lightheadedness, and palpitations.A transmission was reviewed and changes in the left ventricular (lv) lead and right ventricular (rv) lead impedances were noted on the lead trends.Both leads remain in use. no further patient complications have been reported as a result of this event.
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Continuation of d10: 6947m62 lead implanted: (b)(6) 2015; 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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