MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37601 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Tissue Breakdown (2681)
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Event Date 12/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 3387s-40, lot#: va10mhr, implanted: (b)(6) 2015, explanted: (b)(6) 2020, product type: lead.Product id: 3387s-40, lot#: va0zg0e, implanted: (b)(6) 2015, explanted: (b)(6) 2020, product type: lead.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2020, product type: extension.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2020, product type: extension.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 20-aug-2018, udi#: (b)(4).Product id: 3387s-40, serial/lot #: (b)(4), ubd: 23-jul-2018, udi#: (b)(4).Product id: 3708660, serial/lot #: (b)(4), ubd: 01-oct-2019, udi#: (b)(4).Product id: 3708660, serial/lot #: (b)(4), ubd: 01-oct-2019, 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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Information was received by a manufacturing representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient had a possible infection.He did not report this issue prior to coming in for surgery.The patient went in for a routine battery changed.Mentioned during pre-op he was having some bleeding at the top of his head after he washed his hair.Upon further investigation he had two open wounds (scabbed over) and surgeon cancelled the battery change and went in for exploration of these wounds that resided over the stimlock and the lead extension connection towards the posterior aspect of the skull.Once in surgery surgeon decided to take cultures, explant leads and extensions, and stimlock.Surgeon sending all product for culture evaluation.I have requested that we are able to have the products after they are finished, however they were not sure if that was possible due to contamination.Surgeon investigated wounds and found that it was safest for the patient to remove the system.Patient is still in the hospital receiving antibiotic and dr.Vives will follow up with patient in regards to the next steps in regards to the infection and the patient will want to have the surgery once surgeon feels it is possible.
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Event Description
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Additional information was received from a manufacturer representative (rep) reporting an infection was confirmed.The hospital has the devices and will not be returned at this time.
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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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Manufacturer Narrative
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Section d information references the main component of the system.Other relevant device(s) are: product id neu_burrholecap lot# unknown product type accessory product id 3387s-40 lot# va10mhr implanted: (b)(6) 2015 explanted: (b)(6) 2020 product type lead product id 3387s-40 lot# va0zg0e implanted: (b)(6) 2015 explanted: (b)(6) 2020 product type lead product id 3708660 lot# serial# (b)(6) implanted: (b)(6) 2015 explanted: (b)(6) 2020 product type extension product id 3708660 lot# serial# (b)(6) implanted: (b)(6) 2015 explanted: (b)(6) 2020 product type extension 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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Manufacturer Narrative
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H3.As there was no device allegation, analysis was not performed due to non-analyzable 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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