MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 353101 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problems
Urinary Retention (2119); Malaise (2359); Insufficient Information (4580)
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Event Date 01/20/2024 |
Event Type
Injury
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Event Description
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Information was received, from a trial patient.Who was using an external neurostimulator (ens).For urgency frequency and urge incontinence.It was reported, that the patient's trial started on (b)(6) 2024.It was reported, that the patient reported, they had reached maximum settings after switching sides.And increasing the stimulation, but they could not feel the stimulation.Agent assisted the patient with switching from the left side at 7.3 to the right side at 12.2, but the patient reached maximum settings and could not feel the stimulation.After decreasing stimulation to 0.0 on the right side, the patient still reached maximum settings on the right side and could not feel stimulation.Agent switched the patient back to the left side and the patient reached maximum settings at 12.4.The patient then lowered the stimulation to 11.1 where they could still feel the stimulation on the left side.The patient reported, they had urinary retention (can't urinate) were not feeling well/sick.Was advised, the patient to please contact their clinician with questions regarding medical advice or if they have questions about their health.The issue is ongoing.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank, because the information is currently, unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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