Concomitant medical product: dvfb1d4 icd; implanted: (b)(6) 2019; 6935m62 lead; implanted: (b)(6) 2019.Investigation of this event is pending, and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.
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A supplemental report is being submitted for device evaluation.Product event summary: the controller ac adapter was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned device revealed that the controller ac adapter was able to adequately provide power to a test controller.No anomalies were observed on the output cable assembly.As a result, the reported damaged cable event was not confirmed.However, visual inspection revealed that the clamp assembly screw was broken.The clamp assembly contains a screw that ensures that the ac power cord is secure in the adapter receptacle and cannot be pulled out.To enable a secure connection, the screw can be loosened or tightened to allow a proper connection between the ac adapter enclosure and the ac cord.As a result, the reported "broken screw" event was confirmed.A possible root cause of the reported "broken screw" event can be attributed, but not limited, to the handling of the device.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.
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