MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTIAL TREMOR
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Model Number 37603 |
Device Problems
High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Impedance Problem (2950)
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Patient Problems
Electric Shock (2554); Paresthesia (4421); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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It was reported that there was shocking on the left side and the shocking is on and off/comes and goes.Impedance in #2 is 2,093 and #0 is 2,146 with all others in normal range.The right side has low impedances with 0 and 1 that are 536.The patient is not using the contacts to program, but using #3 and getting great control.A full x-ray series was taken for both sides which looked normal and no broken wires were seen.The patient was referred for surgical consult.The issue was not resolved at this time.Additional information was received from the manufacturer's representative (rep) who reported that the shocks come and go with diffe rent positions.
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Manufacturer Narrative
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Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 23-sep-2020, udi#: (b)(4); product id: 3389s-40, serial/lot #: (b)(4), ubd: 06-jan-2019, udi#: (b)(4); product id: 3389s-40, serial/lot #: (b)(4), ubd: 11-oct-2021, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 02-jul-2022, udi#: (b)(4).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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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 manufacturer¿s representative (rep) reported the patient¿s surgery was postponed due to some abnormal labs; no new surgery date was scheduled as of yet.The rep was hoping the surgery would resolve the intermittent tingling.
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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 manufacturer¿s representative (rep) reported the patient had not been rescheduled for surgery yet.
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Event Description
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Additional information received from the manufacturer¿s representative (rep) reported surgery was scheduled today to replace the left lead, but the case was cancelled as the patient declined to continue with revision due to the risk involved.The patient still had the impedance issue on #2 contact with impedance values of 2,300.The right side also had impedance issues with contacts 0 and 1.Nothing was going to be done to address the high impedances on the right side as therapy was being delivered with contact 2-, c+ 2, 2 v, 90 and 195 rate.The patient had good therapy control on the right, and the patient was aware they couldn¿t have an mri.No further investigations or actions were planned.
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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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