MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97714 |
Device Problems
High impedance (1291); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Patient Device Interaction Problem (4001)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 02/04/2021 |
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 a patient via manufacturer representative (rep) who was implanted with an implantable neurostimulator (ins) for non-malignant pain and sciatic nerve injury.Patient is reporting change in coverage and efficacy after unrelated lumbar surgery in area of the leads.She states that her stimulator has not been the same since the surgery and gets very strong when she lays down.The rep was asked to check her system by the healthcare provider (hcp) after lumbar surgery to verify that all connections were good, new x-rays were compared to previously saved images and there appears to me no change in position of the leads.That check was completed previously on (b)(6) 2020.On (b)(6) 2021 rep was contacted by patient reporting loss off efficacy and increased stimulation when she lays down.Rep met with her again at hcp's office to check impedances and programming.At that time rep noticed she does have 1 electrode, 9, reading over 10,000.That lead or electrode were not being used for her programming and it is unclear at this time if that was the case on previous exams. after several failed attempts to adjust her programming to regain her previous comfort and efficacy, rep recommend that she make an appointment with implanting hcp, to have her system evaluated by him.She will make that appointment and follow up with him as soon as possible.It is unknown if the event 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.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 received.The patient is scheduled for a full system replacement on (b)(6) 2021 with hcp.No cause has been determined at this time.
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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 received from the rep indicated that the patient's full system was replaced on (b)(6) 2021.The old leads and stimulator were discarded at time of case.The cause of original lead/therapy issue is unknown.The rep indicated that the patient is doing great.
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