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Model Number 97714 |
Device Problems
Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant products: product id: 977c290, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 977c290, serial/lot #: (b)(4), ubd: 29-mar-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the during a lead revision, the physician was unable to remove the cervical lead from the spine.The physician was pulling harder than he felt comfortable with.The lead tai ls were cut and the incision was closed.The plan is to see if he patient wants another surgery to remove more bone to try and get the lead out.The physician didn't feel comfortable doing that without having the patient properly consented.The reason for lead revision was unknown, and there were no contributing factors that the patient could recall.
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Manufacturer Narrative
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Continuation of d10: product id 977c290, serial# (b)(6), implanted: (b)(6) 2017, 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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Event Description
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The manufacturer representative reported that when the physician tried to pull the lead several times, the lead appeared to start to tear, so he did not want to try anymore.
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Search Alerts/Recalls
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