Model Number 97715 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erythema (1840); Unspecified Infection (1930); Swelling (2091); Alteration In Body Temperature (2682)
|
Event Date 07/01/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
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).It was reported that the patient had an infection around the ins site last summer (clarified last (b)(6)).The skin was red around it and the site was warm and puffy.The patient was given antibiotics (z-pack), which cleared up the infection.[see (b)(4) for additional information regarding the itching/hurting around the ins site and discoloration].
|
|
Manufacturer Narrative
|
Corrections made to h6.Additional patient codes added.Conclusion code corrected.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.
|
|
Event Description
|
Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins).It was reported that the patient had an infection around the ins site last summer (clarified last on (b)(6).The skin was red around it and the site was warm and puffy.The patient was given antibiotics (z-pack), which cleared up the infection.
|
|
Event Description
|
Patient provided weight information.
|
|
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.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
|