MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
|
Back to Search Results |
|
Model Number B35200 |
Device Problems
Break (1069); High impedance (1291); Low impedance (2285); Application Program Problem (2880)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical product: product id neu_unknown_ext lot# unknown serial# implanted: explanted: product type extension product id neu _ins_stimulator lot# serial# unknown implanted: (b)(6) 2019.Explanted: (b)(6) 2023.Product type implantable neurostimulator section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown, ubd: , udi#: country of origin: the netherlands 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 recently had a battery replacement (activa to percept).Prior to the battery replacement the system showed low impedances on several contacts.Nevertheless, it was decided to continue with the battery replacement.After the replacement the system showed elevated impedances (unknown whether these were the same contacts as for the low impedances) and an oor messages was received.Additionally, the patient experienced less efficient therapy effects (return of symptoms, but no shocks).Additional information was received from the manufacturer representative (rep) that the cause of the low impedance was not determined.Different impedance tests were run and stimulation was adjusted on a different contact.The cause of the high impedance was not determined.The patient's symptoms have not resolved.Actions taken to attempt to resolve high impedance and oor included lowering amplitude, pulseiwth, impedance testing, stimulating different contact (which was not comfortable to the patient).The patient will have a revision soon as there is suspected to be a damaged extension.Testing on the battery, extension, and lead will be performed.Refer to manufacturer report 2182207-2023-01303 for related device.
|
|
Event Description
|
Additional information was received from a manufacturer representative (rep) reporting that it is unknown when the revision is scheduled to take place and unknown if any devices will be explanted.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Other relevant device(s) are: product id neu_unknown_ext lot# unknown implanted: (b)(6)2014 product type extension product id neu_ins_stimulator lot# serial# unknown implanted: (b)(6)2019 explanted: (b)(6)2023 product type implantable neurostimulator 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
|
|
|