MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Foreign Body Reaction (1868)
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Event Date 01/30/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient had extension migration/large eroded area of the skin in the retroauricular region of 3cm x 1cm and the extension was exposed.The extension was explanted/replaced and disposed of on (b)(6) 2022.It was stated the patient had a foreign body reaction, but the issue was resolved without sequelae on (b)(6) 2022.
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Manufacturer Narrative
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Concomitant medical products: product id: 3708660.Serial# (b)(4).Explanted: (b)(6) 2022.Product type: extension.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 26-feb-2025, udi#: (b)(4).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 3708660 lot# serial# (b)(6) implanted: (b)(6) 2021.Explanted: (b)(6) 2022.Product type extension 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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