MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 977a260, lot#: none, serial# (b)(4), implanted: (b)(6) 2018, explanted: none, product type; lead.Product id: 977a260, lot#: none, serial# (b)(4), implanted: (b)(6) 2018, explanted: none, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 22-oct-2022, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 11-sep-2022, 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 a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.The reason for call was pt reported the leads have moved around in her back since about 6 months ago - pt stated she had an mri the other day to check the position.Pt stated the revision procedure is scheduled for (b)(6) 2021 - pt has an appt with hcp to talk about the procedure (b)(6) 2021.Pt stated dr john edwards is going to do the procedure.The patient was redirected to their healthcare provider to further address the issue.No patient symptoms were reported. .
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Manufacturer Narrative
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Continuation of d10: product id 977a260, serial# (b)(6), implanted: (b)(6) 2018.Product type lead.Product id 977a260, serial# (b)(6), implanted: (b)(6) 2018.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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Additional information was received.It was reported the doctor would not operate as the patient was 71 years old.The issue was not resolved, the patient continued to keep their device charged.
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Search Alerts/Recalls
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