MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
|
Back to Search Results |
|
Model Number 37612 |
Device Problems
Overheating of Device (1437); Insufficient Information (3190)
|
Patient Problems
Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/19/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Concomitant medical products: product id neu_unknown_lead lot# serial# unknown product type lead.Other relevant device(s) are: product id: neu_unknown_lead, 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 6-8 months ago, the patient felt heat under their skin near their implantable neurostimulator (ins) implant site.The patient stated they met with their hcp who did some type of system check and told the patient they are not mri compliant.The patient stated they were not exactly sure what the condition of the ins system was, but the hcp did mention something about impedance and that "essentially one of the leads is null and dead." the reason for call was caller wanted to know why that would make them not mri compliant.Patient stated they do not have to have an mri, but that they want to be aware for the future.Information was reviewed with caller.The patient was redirected to their healthcare provider to further address the issue.
|
|
Search Alerts/Recalls
|
|
|