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Model Number 97714 |
Device Problems
Migration or Expulsion of Device (1395); Unintended Collision (1429); Patient Device Interaction Problem (4001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 04-feb-2018, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 24-feb-2018, 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.It was reported that the patient's leads have moved.
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Manufacturer Narrative
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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 from the patient.It was reported that the cause of the leads moving was possibly due to a fall, physical work and exercise.The actions that will be taken to resolve this issue is they will be evaluated at the time of battery replacement.The issue has not been resolved yet, they have an appointment scheduled for may 12th to address this.
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Manufacturer Narrative
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Continuation of d10: product id 977a260, serial# (b)(6), implanted: (b)(6) 2014, explanted: product type lead product id 977a260, serial# (b)(6), implanted: (b)(6) 2014, 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 patient stated that the device was replaced for normal depletion as well as the leads shifting.
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Search Alerts/Recalls
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