Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for gastric stimulation.It was reported that the patient had increased muscle spasms.There were no known factors that may have led to this issue and it was not resolved at the time of the report.A procedure was planned for (b)(6) 2020 to have a esophagogastroduodenoscopy (egd) and a diagnostic laparoscopy to check the leads.On (b)(6) 2020, the hcp reported that the planned procedure for (b)(6) 2020 was not done due to other medical issues with the patient and it hadn't been rescheduled.On (b)(6) 2020, it was reported that the patient had pain and visible jumping of the abdomen.It was noted that the patient had a history of back spasms and this could have been related.The stimulation was turned off on (b)(6) 2020 and the patient reported no subsequent jumping of their abdomen.An egd and system replacement occurred on (b)(6) 2020, but the event was noted to not be resolved.It was additionally noted that there were no obvious lead issues.No further complications were reported or anticipated.
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Product analysis #703676425:analysis information -- 2020-08-07 14:25:24 cst pli# 10 product id# 37800 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.Continuation of d11: product id 4351-35, serial# (b)(6), product type: lead, product id: 4351-35, serial# (b)(6), product type lead.Analysis of the ins (nhx708744h) found that there were no significant anomalies.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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