MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number B35200 |
Device Problems
Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091); Discomfort (2330); Impaired Healing (2378); Fluid Discharge (2686); Swelling/ Edema (4577)
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Event Date 09/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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The event date is an estimated date.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), udi#: (b)(4) ; product id: 3708660, serial/lot #: (b)(4), udi#: (b)(4); product id: 3387s-40, serial/lot #: (b)(4), udi#: (b)(4) ; product id: 3387s-40, serial/lot #: (b)(4), udi#: (b)(4); (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 the complete system was explanted today due to infection.The patient's wife noted that a few weeks after implant, the pocket site was red/tender/sore/painful but they were moving and the patient may have been helping with the process and lifting things, so the patient did not pay much attention to it.They went to the emergency room, believed on sunday, and it was found that the pocket site was not healing and oozing.The lead/extension connection incision site behind the ear was red and raised.The patient will not be re-implanted.The patient was explanted in june due to infection at the pocket site as well.The physician speculated that because of the type of infection the patient had in june, the infection may have colonized, and actually never went away.After the june explant, the patient saw an infectious disease healthcare provider (hcp) and they indicated that if the patient got another implant, they would need to be on antibiotics for the rest of their life.After re-implant in september, the patient was placed on antibiotics, but only for 4 days.All explanted products will be returned.
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Event Description
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Additional information received from the manufacturer¿s representative (rep) reported due to the implant technique of ¿countersinking¿ (where a small bevel is made in the skull so the lead has a replace to sit and is less noticeable externally/patient doesn¿t feel it as much¿ the explant of the leads is more difficult.During explant the surgeon made incision at the lead/extension connection site and on top of the head where the lead enters so there was some resistance on the leads down the neck to where the lead/extension connection was.The surgeon was aware of this and didn¿t seem concerned as they removed as much of the casing from the tunneling tract as possible and nothing was left in the skull.Therefore, the rep just had the wire part of the leads to return.The rep was going to return all explanted product.
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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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H3.Analysis of the neurostimulator s/n (b)(6) extensions (s/n (b)(6) and (b)(6), and leads (l/n va1pumk) was not performed as the reported issue is a 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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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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