MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number NEU_ENS_STIMULATOR |
Device Problems
Unstable (1667); Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2022 |
Event Type
malfunction
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Event Description
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It was reported that the door on the burrhole could not be put into ring and the door did not close.Due to manipulation, multiple due to bad closure, the lead changed position.A cause was not known.They took another set with the same serial number and burrhole was checked with no bone or other substance to prevent closure.The issue was resolved.
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Manufacturer Narrative
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Concomitant medical products: product id b32000 lot# (b)(4) serial# product type accessory (b)(4).Other relevant device(s) are: product id: b32000, serial/lot #: (b)(4), ubd: 01-nov-2023, 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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Event Description
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Additional information was received: it was reported there was a delay in the surgery of about 30 minutes.When the lead position changed it was said to be due to manual manipulation of the burrhole, and was placed correctly at the end.It was stated there was a learning curve with the burrhole product.It was not designed to handle multiple manipulation and according to the implanting physician the burrhole was free of substance/bone.It required some "skills" to get it in the right place.The physician was fairly new at implanting those burrholes and experience could've been a part of the issue.
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Manufacturer Narrative
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Concomitant medical products: product id b32000 lot# 082m30521 product type accessory 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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Continuation of d10: product id b32000 lot# 082m30521 serial# unknown implanted: explanted: product type accessory product id b31000 lot# unknown serial# unknown implanted: explanted: product type accessory h3: analysis of the burr hole device had shown that it passed all tests and no anomalies were found.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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