Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel disfunction and urge incontinence.It was reported that the system failed.The patient had an x-ray which showed that the wire was kinked up in two different places and it was not working.Patient had an appointment and everything was working fine.For a couple of days the patient saw no change and then all of a sudden it kicked in and for a while, maybe 2 weeks or something, the patient was happy and then they started to be unhappy again and their symptoms came back.Patient went back to the doctor and they told the patient the system had to be shut down because the wire was not working and there was a kink in the wire.The problem started a couple weeks after the patient got it implanted.Patient had revision surgery scheduled for (b)(6).
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B3: date is approximate.Year is confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 978b128 (lot: va2r4j6); product type: 0200-lead; implant date (b)(6) 2023; 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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