MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
|
Back to Search Results |
|
Model Number 97715 |
Device Problems
Migration or Expulsion of Device (1395); Energy Output Problem (1431); Patient Device Interaction Problem (4001)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 07/01/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a patient (pt) regarding an implantable neurostimulator (ins).Pt reported that if they lay back on their implant, it puts pressure on the actual "unit" (ins).Pt reported that this "triggers" the ins and doesn't stop unless the pt sits up straight and stops putting pressure on the ins.Pt noted that this issue was occurring before, and noted the ins has moved in their back.Pt reported that the ins is sticking out of their body a little more than what it was before.Pt reported if they put pressure on that area, it "shoots".Pt reported that they have to turn the ins off until they can get up.Pt stated the issue started off and on for about 2 months, but for the last 3 days the issue has been getting worse and is more constant.
|
|
Event Description
|
It was reported that the cause was not known.Patient stated it just migrated to where it was now.Patient stated no one has contacted them yet.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|