MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 37714 |
Device Problems
High impedance (1291); Unintended Collision (1429); Energy Output Problem (1431); Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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 the patient via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for radicular pain syndrome (radiculopathies) and spinal pain.The patient has a medical history of spinal cord stimulators, hypertension and chronic pain.It was reported that a couple of months ago the patient¿s spinal cord stimulator went to 10.5.Today at their appointment they reported that they had a fall approximately two months ago that may have contributed to the reported issue.Impedances were run, which revealed that the lead with electrodes 8 through 15 were out of range and greater than 10,000 ohms.The rep reprogrammed using the 0 through 7 lead and the issue was resolved at the time of the report.The event date was asked but was unknown.No surgical intervention occurred or was planned.No further complications were reported/anticipated.
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Manufacturer Narrative
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Concomitant medical products: product id 977a260 serial# (b)(6) implanted: (b)(6) 2014 explanted: (b)(6) 2020 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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A new paddle lead and implantable neurostimulator were implanted.
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Manufacturer Narrative
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Continuation of d10: product id: 3778-60; lot#serial#: (b)(6); product type: lead; product id: 97791; product type: accessory; product id: 3550-39; product type: accessory; product id: 977a260; lot#serial#: (b)(6); implanted: on (b)(6) 2014; explanted: on (b)(6) 2020; product type: lead; h3: analysis of the ins found that it was at normal end of life.Analysis of the lead (b)(6) found the product was segmented, cut through.Analysis of the lead (b)(6) found that the conductor was broken at the titan anchor site.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.
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