MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number NEU_ENS_STIMULATOR |
Device Problems
Break (1069); High impedance (1291); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2024 |
Event Type
Injury
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Event Description
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It was reported that the second electrode was implanted, connectivity and impedances were measured with the programmer, and reports were high: more than 20,000.The doctor ordered to change the test cable, remove the electrode and clean it.Subsequently, they proceed to implant it, measure impedances again and report high levels: more than 20,000.The neurologist ordered to change the electrode with a new one.Impedance is measured: 1350.The neurosurgeon implanted the electrode.The manufacturer representative (rep) stated the electrode was damaged and had poor connectivity.
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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 (b)(6); product id 3389-40 (lot: va2n42g); product type: 0200-lead; implant date (b)(6) 2024; explant date (b)(6) 2024.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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