MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
|
Back to Search Results |
|
Model Number 37601 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Muscular Rigidity (1968); Unspecified Nervous System Problem (4426)
|
Event Date 06/17/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id: neu_unknown_lead, lot#: unknown, product type: lead.Product id: neu_unknown_ext, serial#: unknown, product type: extension.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown; product id: neu_unknown_ext, serial/lot #: unknown.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.
|
|
Event Description
|
It was reported that the patient came to clinic with severe right head tilt and feeling that deep brain stimulation (dbs) had been minimally helpful.He felt his overall quality of life had not improved.The device was reprogrammed, but setting change was not helpful.Voltages had to be lowered because higher ones caused tightness sensations.The patient questioned if the leads were in the right position due to partial response to treatment.Right head tilt was improved during following visit, and the settings were again changed to higher amplitude with interleaving.The patient felt they were not doing as well since settings were lowered.An mri was planned to check the lead position.Diagnostics to date included examinations.Etiology was considered related to device/therapy and not related to procedure.The outcome was ongoing.The clinical diagnosis was severe cervical dystonia.Additional information was received stating that the intervention that occurred included suspending therapy.The device turned off to gauge how much benefit dbs provides patient.Action date: (b)(6) 2022.Additional information was received: it was reported that the patient went back into the clinic and wasn't doing well after their last programming.They had moderate head tilt and only some improvement after reprogramming.Additional information was received: it was reported that the patient had their old left gpi lead removed and a new one implanted.They also had their left ins removed and replaced.Their right extension was also removed and replaced.
|
|
Manufacturer Narrative
|
Continuation of d10: product id 3389s-40 lot# va23ed2: product type lead product id 3708660 serial# (b)(6): product type extension 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.
|
|
Event Description
|
Additional information was received: it was reported that the products were explanted due to the patient's choice and severe cervical dystonia.The event was still ongoing.
|
|
Manufacturer Narrative
|
Extension serial number could also be (b)(6) lead lot number could also be va25b78 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.
|
|
Search Alerts/Recalls
|
|
|