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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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| Model Number 37601 |
| Device Problems
Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896); Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Wound Dehiscence (1154); Headache (1880); Muscular Rigidity (1968); Pain (1994); Chills (2191); Anxiety (2328); Discomfort (2330); Complaint, Ill-Defined (2331); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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Information references the main component of the system.Other relevant device(s) are: product id: 37642, serial#: unknown, product type: programmer, patient.Product id: 3389s-40, lot#: va1zq66, implanted: (b)(6) 2019, product type: lead.Product id: 3389s-40, lot#: va1v05a, implanted: (b)(6) 2019, product type: lead.Product id: 3389s-40, serial/lot #: (b)(4), ubd: 19-feb-2022, udi#: (b)(4).Product id: 3389s-40, serial/lot #: (b)(4), ubd: 23-jul-2021, 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 from a consumer who stated that at ¿the end of 2019, beginning of 2020¿ their lead wires inside the top of their head were ¿pulling so hard,¿ they could feel them and it ¿hurt like heck.¿ the consumer stated a month and a half ago they had a revision done for the lead on the right side.Since the revision, the consumer had ¿twice the anxiety¿ and had a tremendous amount of pressure in their head due to the position of the lead wires along with pain in their face.The consumer wasn't sure if they needed another revision or reprogramming because they hadn't been feeling great since the revision.During the call the consumer attempted to check the status of the implant with the patient programmer (pp) and saw the poor communication screen (with the antenna).The consumer then synced the pp with the implant on the first attempt (with the antenna) which worked and showed the implant was on a nd the battery was okay with voltage at 2.95.The consumer was going to speak with their 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 was received from the consumer reporting they received the replacement patient programmer (pp) antenna and now the pp is communicating with their ins.They added that the lead wires are sinking inside their head and are "pulling the battery" even when they are sitting still.They stated they are "double-stitched" where the leads are and the stitches are splitting open on their scalp.They have reported this to their surgeon but they are not helping the patient.Their anxiety has been better in the last five days and they have been doing physical therapy.They are scheduled to meet with the physician today and the patient was advised to discuss these concerns with the hcp as they are a medical professional.
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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 the consumer reporting they received the replacement pp antenna and the pp now the pp is co mmunicating with their ins.They added that the lead wires are sinking inside their head and are "pulling the battery" even when they are sitting still.They stated they are "double-stitched" where the leads are and the stitches are splitting open on their scalp.They have reported this to their surgeon but they are not helping the patient.Their healthcare provider (hcp) seems to be attributing their concerns to high anxiety, but their anxiety has been better in the last five days and they have been doing physical therapy.They are scheduled to meet with the physician today and the patient was advised to discuss these concerns with the hcp as they are a medical professional.
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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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The patient said the cause of the pulling was not determined.Imaging is scheduled for (b)(6) 2020.The cause of the symptoms and anxiety was not determined.A blood test was done and it was confirmed there was no infection.They mentioned they have pressure in their head.They wont reprogram the patient.She said the disfiguration in her head was due to wires pulling and migrating.
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Manufacturer Narrative
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Section d information references the main component of the system and other applicable components are: product id 3389s-40 lot# va1zq66 implanted: (b)(6) 2019 product type lead product id 3389s-40 lot# va1v05a implanted: (b)(6) 2019 product type lead product id 37092 lot# serial# unknown 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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Event Description
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Additional information was received from the patient stating that she needed help because she was "having one of her episodes again" and she does not believe the device is working.Patient stated that she was currently having an episode and stated, "my toes are spasming, my head has pressure, my muscles are like here and there especially around my neck, my legs are spasming, and my calves are stiff."patient was confusing and repeated information already documented below, including that she has horrible pressure in her head and that she has tried to meet with her doctor in the past and he refused to see her or program her.Patient stated that she now sees a different hcp and has an appointment with him tomorrow.Patient states that she would like to have a manufacturer's representative (rep) there to check the ins and assist with the programming.Patient mentioned something about "syncing leads during surgery" but when asked for clarification, patient just kept repeating herself.An email was sent out to the rep.Patient also noted that she met with the doctor and there was no rep, it was indicated that the doctor said everything was ok and that the rep didn't need to be there.
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Manufacturer Narrative
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D10.Section d information references the main component of the system.Other relevant device(s) are: product id 37092 lot# 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.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 provided that the next appointment is on (b)(6)2020 with her neurosurgeon, she can feel pressure in her and mentioned that she can feel all of the leads in her head and and continues to experience discomfort from the ins battery.Patient called back on(b)(6) 2020 and stated that her programmer antenna was broken for a long time and not communicating with her implant.Patient stated their provider will not work with them.
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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 stating that the patient's symptoms and anxiety are getting worse.They were seeing poor communication with the antenna but were able to connect just fine without it.They stated they feel like they have something like an infection because they have been getting chills and are off.Patient kept repeating that she needs to be reprogrammed to help fix whatever is going on.
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Manufacturer Narrative
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D10: section d information references the main component of the system.Other relevant device(s) are: serial# (b)(6) product type extension product id 3708660 lot# serial# (b)(6) product type extension product id 37092 lot# serial# unknown 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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Event Description
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Additional information was received from the consumer reporting the battery pulls outward and upward as the wires tighten.They do not know if the leads moved.No imaging was done to determine the cause of the leads pulling/battery pulling/pain.A scan was done to make sure of no problems as far as pressure in their head.It was determined to check on cause of wires pulling, etc.They have no clear explanation and the wire is very short from the battery up to their neck.The cause of the worsening symptoms and anxiety was not yet determined.They saw their neurologist on (b)(6)2021 and they did some programming.They are still trying to find out what steps to take to resolve the chills and the physician mentioned medication.The chills did not resolve.They are not sure what is going to be done about the chills yet.
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Search Alerts/Recalls
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