A supplemental report is being submitted for analysis and investigation completion.Product event summary: the controller (con406790) was returned for evaluation.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Review of the controller log files did not reveal any anomalies within analyzed period.Visual inspection of the controller revealed that the serial cap was missing and there was contamination within the serial port.Visual inspection also revealed scratches on the controller's liquid crystal display (lcd) on the front panel window.These are additional findings not related to the reported event, which can likely be attributed to wear and/or the handling of the device.Failure analysis of the returned controller also revealed a loose, detached power port two (2) connector with exposed wires.Internal visual inspection revealed a loose metal locknut from power port two (2) in the controller.Furthermore, an internal inspection did not reveal evidence of fluid ingress.A visual inspection under 10x magnification revealed that the thread of the connector did not have an adequate application of the loctite substance.As a result, the reported event was confirmed.The most likely root cause of the reported loose connector event can be attributed to improper assembly.Capa pr00508470 was opened to investigate loose connectors with controller 2.0.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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