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); Pain (1994)
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Event Date 03/30/2023 |
Event Type
Injury
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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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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that ever since implant they can't hold their water.Patient said they called the manufacturer representative (rep) and asked them to turn it up a little bit, patient said the representative turned it up too much and patient did not say anything to the representative because they knew they were going to have it taken out because it was not helping their symptoms and patient said the device has been removed by their doctor.Patient reported ever since the representative increased it, they have real terrible pain in their left butt cheek which gets worse if they sit for a while or they bend down to pick something off the floor and when they come back up they almost fall because it hurts so bad.Asked patient if they had been working with a doctor to resolve the issue and patient said no they called their doctor who did the ins and the receptionist told them to call patient services.Reviewed the option to work with a medical doctor to resolve medical symptoms.The patient was redirected to their healthcare provider to further address the issue.
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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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Event Description
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Additional information was received, from a healthcare professional (hcp).The hcp reported, that the device removal was elective.It was unknown, if the issue was caused by normal battery depletion.And the most likely cause of the issue was "psych issues".
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Search Alerts/Recalls
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