MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Incontinence (1928); Unspecified Infection (1930); Hematuria (2558); Dysuria (2684)
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Event Date 03/30/2023 |
Event Type
Injury
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Event Description
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Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.Pt said they do not feel any different their interstim is not working to help their symptoms, they still have a lot of accidents and don't make it to the toilet.Pt said at about 2 weeks after implant healthcare provider (hcp) took xrays and changed the program, they were trying to give it some time but right now they are experiencing bladder pain and bleeding in their urine, this started on saturday.Redirected to their doctor to resolve their medical symptoms of bladder pain and bleeding in their urine.Pt said they saw their regular doctor for a urine test and got antibiotics, they called their interstim doctor but has not heard back.Pt requested assistance to use the equipment to make a change to their setting.Worked with pt to synch with their ins and they were on program 2 at 5.6, asked pt to reduce program 2 to 1.7, and patient services (pss) asked pt if the pain got any better but pt said they could not tell.Assisted pt to change the program to program 3 and pt increased to confirm a comfortable setting.Reviewed some interstim information and the patient was redirected to their healthcare provider to further address the issue.
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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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