MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Flatus (1865); Loss of consciousness (2418); Abdominal Distention (2601); Insufficient Information (4580)
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Event Date 10/11/2022 |
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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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and urina ry/bowel dysfunction.It was reported that patient is having trouble going to the bathroom since last night.Patient said that last night they were full of gas, abdomen was distended and patient passed out 4-5 times.Patient said that they fell once (a result of passing out) and cut themselves up due to the fall.Patient said that they went a little bit, however reports issue for passing out is still occurring.Patient said that the stool is formed, is thicker than water.When asked, patient said that two days ago they stopped taking a stool softener medication (over the counter) because stool was too loose however the stool has been hard the last two days.Patient would like to connect to implant and having difficulty connecting.Troubleshooting reviewed therapy information and general programming guidance.After consulting with mobility, caller was able to assist patient to connect to implant and said that patient's setting is currently at 0.2.Patient said that the last adjustment was made at hcp office at post-op follow up appointment.Based on symptoms, patient turned therapy off and redirected patient to contact their hcp to review symptoms and report that patient stopped taking medication before making any further adjustments.The patient's relevant medical history included that right before received current implant, that her whole body took over when previous ins battery depleted.Patient said that the gastroenterologist said that bowel started pushing stool back upwards.Patient said was septic and admitted to hospital on (b)(6) and was hospitalized for 10 days.
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Search Alerts/Recalls
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