MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problems
Break (1069); High impedance (1291); Unintended Collision (1429); Connection Problem (2900)
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Patient Problem
Dyskinesia (2363)
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Event Date 10/27/2023 |
Event Type
Injury
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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 activa; product id 37085-40 (serial: (b)(6)); product type: 0191-extension; implant date (b)(6) 2011; explant date (b)(6) 2023 brand name activa; product id 3387s-40 (lot: v727699); product type: 0200-lead; implant date (b)(6) 2011; explant date.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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It was reported that high impedances, decrease in efficacy, and increase in dyskinesia.The patient fell in may, undetermined if related to issue or not. per neurologist, programming to try and correct.Noticed all impedances were on left side high x-rays performed, exploratory surgery was planned.Opened pocket, rotated extension ports, impedance issue followed extension.Md opener site at lead/extension connection.Lead tested = visually damaged but impedances ok.Md retunneled new extension.However lead was in place and showed damaged, unable to connect lead to extension.Extension capped with boot.Plan to replace lead with further surgery another day.The issue was not resolved.
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Manufacturer Narrative
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Analysis of the extension (s/n (b)(6)) found the distal end of the conductor was broken due to overstress and the connector on the distal end was twisted in molded rubber.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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B5: after the file was reviewed, coding was removed from the main device and is just being applied to the associate lead and extension.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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