MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number B35200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Seroma (2069); Swelling/ Edema (4577)
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Event Date 06/03/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient had recurrent fluid collections around the stimulator (ipg) site.Surgical intervention included a rad us guided fine needle aspiration of chest wall fluid collection.There was a softball sized seroma at the site.This was indicated to be related to the device or therapy as well as the implant procedure.She has continued to note increase in swelling around the right chest placement and she states that this was not present on her last surgical checkup.She denied pain, warmth, or redness at her visit on (b)(6) 2021.The fluid collection has decreased significantly.It is no longer tense.The issue is unresolved with no further action planned.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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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 from a manufacturer representative (rep) reporting that the exact cause of the event is not known.The chest wall fluid was collected on 2021 (b)(6), chest wall aspiration on 2021 (b)(6) and ins pocket exploration on 2021 (b)(6).The event is unresolved with no further actions planned as of 2021 (b)(6).
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Search Alerts/Recalls
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