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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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| Model Number 37612 |
| Device Problems
Electromagnetic Interference (1194); Energy Output Problem (1431)
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| Patient Problems
Dysphasia (2195); Sleep Dysfunction (2517); Insufficient Information (4580)
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| Event Date 10/29/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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The event date is an estimated date.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 they feel like they are not getting the "juice" in the past couple of weeks.They clarified that they feel like they did before the deep brain stimulation (dbs).When they got the implant, it totally fixed their hiking, biking, everything then about 3 weeks ago, they had a couple dermatology appointments on the leg and nose.They wondered if the cautery of these procedures did something.They stated after the procedure, they felt like they had lost blood or something and did not sleep well for a couple nights and kept feeling worse and worse.Now, it feels like they did before the device was implanted.They checked the ins with the programmer and it showed the same setting and ins is on/ok.They did not shut off the ins before having cautery.They were redirected to the healthcare provider (hcp).
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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 received from the consumer reported they didn¿t have any blood loss.The consumer stated their deep brain stimulation (dbs) was tow years old and worked perfectly for them, however, the consumer started feeling ¿puny with no stamina¿ and they were trying to think of anything that would make them feel better.The consumer stated they saw their neurologist and there was no device issue as the electronics check out and their bloodwork was fine.The consumer¿s physician turned up their voltage 0.2 and now they thought their original hemi-dystonia symptoms reappeared gradually.The physician said they could try another increment increase in two weeks.The consumer¿s physician was currently offering telehealth visits and they felt hey needed an in-person appointment for ¿programming tweaking¿ whenever it was possible.
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Event Description
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Additional information was received from the consumer reporting loss of therapy.They mentioned that "vocal dystonia" is one of their symptoms.They stated that the therapy issue has continued despite meeting with their healthcare provider (hcp) multiple times for reprogramming.They added that their hcp interrogated the ins and noted that "as far as they can tell, the electronics are working." in regards to reprogramming the ins, the patient stated that if they turned it up a certain amount, they would get unwanted side effects like "pulling of the mouth".They are scheduled for an mri.They inquired if cautery could have potentially damaged the ins.They do not recall if the cautery touched their ins.Cautery compatibility information was reviewed.They inquired what could have caused the ins to suddenly stop providing them therapy, noting that the ins worked perfectly for 2 years until they lost the therapeutic effect.The patient mentioned that they did a lot of biking, hiking, and walking.It was reviewed that certain activities that include sudden, excessive, or repetitive bending, twisting, or stretching can cause damage to ins components.The patient denied participating in such activities.The patient confirmed that in early on (b)(4) 2020 they went over the handlebars of their mountain bike and landed on their forearms and leg, but did not hit their head.The patient added that they had "kind of a jolt" when they landed on the dirt.The patient confirmed that they reported this to their hcp, but stated that the hcp's "theory" was that if falling off the mountain bike caused any of the ins components to move, then the patient would have been symptomatic immediately.The patient stated that their "ill effects" didn't occur until 2 months after they fell off the mountain bike.They were directed to the hcp to further address the issue.
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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.
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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 received from the consumer reported therapy was perfect for 2 years and then starting in roughly november they noticed it felt like it wasn't working at all, so they kept checking to see if therapy was even turned on.The consumer stated they knew the ¿electronics¿ of the implant were still working because when they went to their neurologist and have stimulation turned up, they still get the ¿weird side effects and stuff.¿ the consumer felt like something was different and they didn't know why it wasn't helping with their symptoms.The consumer was redirected to their healthcare provider (hcp).
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