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
Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994)
|
Event Date 03/26/2024 |
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 urinary/bowel dysfunction, urge incontinence.It was reported that they are running a "fever in their butt", incision might be infected, it hurts when it is touched and it is bleeding a little bit.The patient was redirected to their healthcare provider to further address the issue.Device education was not reviewed.Additional information was received from the patient.Patient returning call, he is still experiencing the infection on the implant.Referred to hcp.
|
|
Search Alerts/Recalls
|
|
|