Continuation of d10: product id 977a290 lot# serial# (b)(6), implanted: (b)(6) 2016, explanted: product type lead product id 977a290 lot# serial#(b)(6), implanted: (b)(6) 2016, explanted: product type lead.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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On 2023-dec-18, information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins).The reason for call was the caller indicated that they were doing a ins replacement case and they found black inky material in the ins pocket site.The caller indicated that the material does not show up on x-ray.The ins connection looks normal and the impedance values were normal.The caller stated that they plan to have the black material cultured.Troubleshooting was not required.The issue was not resolved through troubleshooting.Tss did not have an explanation for the material found in the pocket.The caller may return the ins for analysis.On 2024-jan-09, additional information was received from the manufacturer representative (rep) reporting that the only reason for the ins replacement was due to the battery approaching end of life and it therefore was replaced proactively.There were/are no issues related to he device/therapy/etc.The patient didn¿t experience any symptoms related to the black ink material.The doctor brought a spine surgeon in during the procedure to take a look at the black ink material.It was thought to be metallosis, potentially as a result of the leads rubbing on the back of the ins.The physician washed and rinsed the pocket multiple times in order to clear the back inky substance out.It was their belief that the metallosis had been resolved.The pocket was cleaned thoroughly, and the old battery was replaced with a new one.The hospital was sent the explanted battery to their lab for pathology.The device has not been returned yet as the rep is waiting for it to be done with the hospital¿s pathology first.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.
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