Model Number 37603 |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problem
Neck Pain (2433)
|
Event Date 02/12/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 16-mar-2019, udi#: (b)(4).Date of event is an approximate.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for dystonia and deep brain stimulation (dbs) therapy indications.It was reported by the patient that before, "the wires were up on top of the battery and now they seem to be on top of the battery".The patient then said she has had "alot of pain in the muscles they are really right on that side of their neck, the same side as where the wires run along the neck for a few days.No trauma/falls were reported that could be related to the issue.No further complications were reported or anticipated with this event.
|
|
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
|
|