MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Energy Output Problem (1431)
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Patient Problems
Incontinence (1928); Device Overstimulation of Tissue (1991); Pain (1994); Urinary Frequency (2275); Distress (2329); Discomfort (2330); Irritability (2421); Paresthesia (4421); Suicidal Ideation (4429); Sexual Dysfunction (4510); Insufficient Information (4580)
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Event Date 08/02/2022 |
Event Type
Injury
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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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Event Description
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Additional information was received from the patient.They reported ongoing concerns with interstim therapy and overstimulation.The patient reported in order to get therapeutic effect they have to increase the stimulation to a level where it is throbbing and painful for them.They also have vaginal dryness, odor, and decreased sex drive.When patient decreased stimulation then they started running to the bathroom all day and night.Patient is very discouraged and was having suicidal thoughts because of this.Troubleshooting reviewed option to change programs and patient opted to do so.Patent changed programs and adjusted stimulation strength to a comfortable level.They will monitor symptoms and continue trying different programs if needed.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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