Model Number 37612 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
Patient Problems
Adhesion(s) (1695); Scar Tissue (2060)
|
Event Date 04/12/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2014, product type: extension.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 13-jun-2017, udi#: (b)(4).Product id: 3708660, serial/lot #: (b)(4), ubd: 12-jul-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the patient had revision surgery on monday, due to bowstringing of the extension wire.Patient said the healthcare provider cleaned out the scar tissue at the neurostimulator site and along the extension to allow better strain relief.Patient said issue started since his implant in april.Discussed individual body response to implant that causes scar tissue or deposits at implant site.
|
|
Event Description
|
Additional information received from the consumer reported they had a revision surgery which involved the surgeon cleaning out some of the scar tissue at the implant site and along the extension.With the same revision the consumer believed the surgeon also rotated the implant because they thought the rubber coating on the neurostimulator was ¿snagging the extender wires¿ which was ¿due to a poor design which they had seen in 5% of their patients (no patient information available).
|
|
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
|
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
|
Additional information received from the consumer reported the previously mentioned bowstringing/tethering resulted in the implant b eing rotated 90 degrees.
|
|
Search Alerts/Recalls
|
|