MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 37714 |
Device Problems
Migration or Expulsion of Device (1395); Material Deformation (2976); Positioning Problem (3009); Insufficient Information (3190)
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Patient Problems
Ambulation Difficulties (2544); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 39565-65, serial# (b)(4), implanted: (b)(6) 2012.Other relevant device(s) are: product id: 39565-65, serial/lot #: (b)(4), ubd: 08-mar-2016, 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 (pt) regarding an implantable neurostimulator (ins).The reason for call was for about the last 6 to 8 months sometimes the pts therapy would work and sometimes it would not; in the last 4 or 5 days it wont work at all.Pt said one of the wires is kinked and they can't use it.Pts doctor won't do work to resolve the kinked lead as the pt had a bad heart.Pts ins is in their hip and leads are in the back.
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Event Description
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Additional information was received from the patient.It was reported the cause of the kinked lead was not determined.The patient reiterated that no steps were taken to resolve the kinked lead due to their heart.The issue was not resolved.
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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.It was reported the implant had not worked because the leads had come off the device.The patient noted the device had not worked since last year (b)(6) 2021.The patient stated their doctor would not do anything because they had a bad heart.The implant bulged out and they had trouble with their feet, had surgery on them, and could not walk.It was noted the patient was short of breath on the call.
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Manufacturer Narrative
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Continuation of d10: product id 39565-65 lot# serial# (b)(6),implanted: (b)(6) 2021explanted: 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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