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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It was reported that whilst trying to implant the leadless implantable pulse generator (ipg), the ipg exhibited loss of capture and rising and high thresholds as a result of patient anatomy.The ipg was initially reprogrammed to max output, implanted and the following day was inactivated and replaced by a new leadless ipg.No patient complications have been reported as a result of this event.
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