MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
|
Back to Search Results |
|
Model Number 97800 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Diarrhea (1811); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/11/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Continuation of d10: product id 978b128, lot# va2wyxg, implanted:(b)(6) 2024, product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(6), ubd: 03-oct-2025, udi#: (b)(4).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 fecal incontinence and urinary dysfunction.It was reported that patient states they felt like the lead had moved and feels near their groin area.Patient bladder symptoms are much improved over baseline since implant but they also mentioned diarrhea.
|
|
Manufacturer Narrative
|
Continuation of d10: product id (b)(4) lot# va2wyxg implanted: (b)(6) 2024 product type lead 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
|
Additional information was received from a healthcare professional (hcp).The hcp reported that patient was contacted and issue was resolved.
|
|
Search Alerts/Recalls
|
|
|