MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Disconnection (1171); Migration or Expulsion of Device (1395); Overheating of Device (1437); Battery Problem (2885)
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Patient Problem
Pain (1994)
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Event Date 01/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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B3: date is approximate.Month and year are confirmed valid.Continuation of d10: product id 977a260 serial: (b)(6) product type: 0200-lead; product id 977a260 serial: (b)(6); product type: 0200-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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Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins).It was reported that the patient felt searing heat in the ins pocket even when the device was off.The patient also stated it was depleting prematurely, however, it was noted that the device was still lasting for over a day before needing to be recharged.The rep was going to meet to discuss lower energy programming.The cause was not determined and the issue was ongoing.
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Manufacturer Narrative
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Continuation of d10: product id 977a260, serial# (b)(6), implanted: (b)(6) 2019: product type lead product id 977a260, serial# (b)(6), implanted:(b)(6) 2019, product type lead product id 977a260, serial# (b)(6), implanted: (b)(6) 2019, 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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Rep stated only related to the depletion from high settings.One lead had migrated and was subcutaneous.The physician believes this is causing the patients symptoms.Revision has been planned.
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Event Description
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Additional information was received from the patient.The patient mentioned one of the leads had become disconnected and lodged somewhere down deep on the right (dorsal) side of their spine.Patient stated they were trying to work with their hcp in california because they trusted and preferred them and that doctor had performed a 9.5 hour long surgery on them 2 years ago.
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Manufacturer Narrative
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Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2019.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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