MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
Incontinence (1928)
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Event Date 02/27/2024 |
Event Type
malfunction
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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 urinary/bowel dysfunction and urge incontinence.It was reported that they noticed about a week ago they saw a message that said: end of service therapy has stopped, please replace the internal device.Patient said they turned it off and back on and in less than a week they saw the message again and they thought the stimulator should last 15 years.Reviewed eos information and redirected to their doctor.Patient reported they have been using a lower setting of 5 or 6 for about the last year or so, they noticed they needed it more but then they had both urinary and fecal incontinence so they were jockying it around which made it wonderful and it has worked great, it has been phenomenal.Pt said they called their doctor who said they were sorry but they have "no information for you".Offered and sent hcp listings.
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Manufacturer Narrative
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B3: date is estimated; month and year are valid.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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