A patient reported they had their device implanted on (b)(6) 2015, when they were able to sit up on their own, they noticed the stimulator was flipping.They stated it turned over and they could see it, because the healthcare provider (hcp) did not tack it down.They went back to the hcp in (b)(6) 2015 and they tacked it down.The patient noted that they could not sit up on their own before because the hcp cut all her stomach muscles and they had a j-tube.The patient further stated that the hcp's claimed they did liposuction, but they did not and the patient said all they did was "cut the big line and put mesh in there".No further complications were reported.
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Additional information received from a consumer (con).It was reported that the hcp didn¿t pack the implant down during the implantation.They were malnourished when it was implanted, so they didn¿t have any fat to insert into the top of the implant.The patient noted that, then, the leads were shocking them.
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Continuation of d11: product id 4351-35 lot# serial# (b)(6), implanted: (b)(6) 2015, product type lead; product id 4351-35 lot# serial# (b)(6), implanted: (b)(6) 2015, product type lead.Due to imdrf harmonization, method, results, and conclusion codes were updated.Conclusion code 67 applies to the ins and code 22 applies to the leads.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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