MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37602 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Purulent Discharge (1812); Unspecified Infection (1930); Swelling/ Edema (4577)
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Event Date 06/04/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 3387s-40, lot#: v433167, implanted: (b)(6) 2010, explanted: (b)(6) 2021, product type: lead.The main component of the system.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 05-jan-2013, udi#: (b)(4).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 the healthcare professional (hcp) stated the patient had an infection and revision (ins removal or lead removal) on (b)(6) 2021, but then indicated it was not performed at their facility. the agent was unable to find any explants or implants on (b)(6) 2021.
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Event Description
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Additional information was received.It was reported that the patient presented with noninfected erosion over the left connector site about 6 months prior.It was initially treated with debridement and scalp closure on (b)(6) 2020.The patient then presented approximately 3 months later with superficial infection at the connector site.Salvage was attempted again on (b)(6) 2021.Patient was treated with antibiotics and appeared to heal quite well.In mid-april was when the patient presented with swelling over the ipg site and with expressible purulent drainage from the connector site.The frontal burr hole site had no signs or symptoms of infection but given the purulent infection at the connector site, the intercranial electrode was presumed to be irreversibly infected and the entire system was removed.
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Manufacturer Narrative
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Continuation of d10: product id 3387s-40, lot# v433167, implanted: (b)(6) 2010, explanted: (b)(6) 2021, product type lead product id 7482a51, serial# (b)(6), implanted: (b)(6) 2010, explanted: (b)(6) 2021, product type extension product id neu_burrholecap, serial# unknown, explanted: (b)(6) 2021, product type accessory h3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 the consumer that they had no previous medical history to report related to the infection.
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Manufacturer Narrative
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Continuation of d10: product id: 3387s-40, lot# v433167, implanted: (b)(6) 2010, explanted: (b)(6) 2021, product type: lead; product id: 7482a51, serial# (b)(6), implanted: (b)(6) 2010, explanted: (b)(6) 2021, product type: extension; product id: neu_burrholecap, serial# unknown, explanted: (b)(6) 2021, product type: accessory.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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Continuation of d10: product id 3387s-40 lot# v433167 serial# implanted: (b)(6) 2010 explanted: (b)(6) 2021 product type lead product id 7482a51 lot# serial# (b)(6) implanted: (b)(6) 2010 explanted: (b)(6) 2021 product type extension product id neu_burrholecap lot# serial# unknown implanted: explanted: (b)(6) 2021 product type accessory h3: implantable neurostimulator ((b)(6)), lead (v433167), extension ((b)(6)), and burr hole device were non-analyzable for medical issue.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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