MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
|
Back to Search Results |
|
Model Number 3058 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Nerve Damage (1979); Pain (1994); Ambulation Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/11/2024 |
Event Type
Injury
|
Event Description
|
Information was received from a patient with an implanted neurostimulator (ins) for fecal incontinence and urinary dysfunction (incontinence, urgency, and/or frequency).It was reported that the lead had an issue.Patient stated they have nerve damage, are unable to walk some days and have pain in lower back.
|
|
Manufacturer Narrative
|
Continuation of d10: product id 3889-33 lot# (b)(6) serial# implanted: (b)(6) 2017 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3889-33, serial/lot #: (b)(6), ubd: 02-jun-2021, 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.
|
|
Search Alerts/Recalls
|
|
|