Product analysis: analysis was unable to confirm the customer comment that the epg failed an atrial sensitivity test as the device passed all automated and bench sensitivity testing with no anomalies observed.It was noted that there was evidence of a non company representative disassembling and reassembling the device as there was one missing plug and two other plugs not fully inserted into the lower case.The epg failed the incoming ventricular pace pulse noise test and the main printed circuit board (pcb) was noted to be out of specification (electrical).Two case screws were noted to be contaminated.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.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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