Model Number 97800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Wound Dehiscence (1154)
|
Event Date 04/11/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient had incision reopening/split open.Patient reported to the urology clinic and was instructed to go to the er.This patient has a bilateral implant and are not yet aware of which side the issue is on but it is not affecting both sides.Will update the side once known.
|
|
Event Description
|
Additional information was received from a manufacturer representative (rep).The rep reported that both sides were affected.The cause of the incision reopening was not determined and all causes are unknown.The incisions were closed and irrigated with antibiotics.It was reported that the issue was resolved.
|
|
Manufacturer Narrative
|
Continuation of d10: product id 97800 lot# serial# unknown implanted: (b)(6) 2024 explanted: product type implantable neurostimulator product id 978b128 lot# unknown serial# implanted: (b)(6) 2024 explanted: product type lead product id 97800 lot# serial# unknown implanted: (b)(6) 2024 explanted: product type implantable neurostimulator medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Search Alerts/Recalls
|