MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number NEU_INS_STIMULATOR |
Device Problems
Break (1069); High impedance (1291); Unintended Collision (1429)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/09/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient fell down a few months ago and since then, their parkinson's disease symptoms got worse.The lead was broken.Impedance reading was performed and some of them were above normal level.A few days after the first check, the impedance in all contacts were above normal readings and the patient's symptoms worsened.The lead that had high impedance was removed and replaced.The new one had normal impedance level when tested.The issue was resolved.
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Manufacturer Narrative
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Section d references the main component of the system.Other medical products in use during the event include: brand name sensight; product id b3300542 (serial: (b)(6)); product type: 0200-lead; implant date (b)(6) 2023; explant date (b)(6) 2023.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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H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that conductors #2 #3 #4 #5 #7 were broken 5.2cm from the proximal end.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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