MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
|
Back to Search Results |
|
Model Number 97800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
|
Event Date 06/28/2023 |
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 urinary/bowel disfunction and urge incontinence.It was reported that around the time the patient got the implant maybe a couple weeks after it was implanted their whole body started itching from their head down to their toes.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the patient.They reported that the cause of the itchy from head to toe was due to patient being allergic to the nickel in the wire that connects to their bladder.Hcp is removed the device on(b)(6)2024.Not yet resolved.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|