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); Migration or Expulsion of Device (1395)
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Patient Problems
Therapeutic Response, Decreased (2271); Insufficient Information (4580)
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Event Date 11/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 21-apr-2021, 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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Patient states that she is not getting the relief in her neck that she had previously gotten with the stimulator. it was unknown if there were any external or patient factors that contributed to the issue. checked impedances and electrodes 1 and 6 were open circuits.Also x-ray was performed and it was noted that the left lead had migrated from c2 to c3. reprogrammed around the open circuits and the patient made an appointment with the implanting physician to discuss further action if reprogramming doesn't work.The issue was not resolved at the time of the report.
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Manufacturer Narrative
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Continuation of d10: product id 977a275 lot# serial# (b)(6) implanted: (b)(6) 2017 explanted: (b)(6) 2020 product type lead product id 977a275 lot# serial# (b)(6) implanted: (b)(6) 2017 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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Additional information was received.It was reported the leads would not be returned as medtronic did not have possession of the device, the customer had discarded the device.
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Event Description
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Both cervical leads replaced with tips at c2.Bilateral coverage obtained, patient experiencing stim in desired areas.
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Manufacturer Narrative
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Continuation of d10: product id: 977a275; lot# serial#: (b)(6); product type: lead.Product id: 977a275; lot#serial#: (b)(6); implanted: on (b)(6) 2017; 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.
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