MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Overheating of Device (1437)
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Patient Problems
Pain (1994); Burning Sensation (2146); Impaired Healing (2378)
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Event Date 02/28/2024 |
Event Type
malfunction
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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 urinary/bowel disfunction and urge incontinence.It was reported that they get a burning sensation at the implant location especially if they were sitting for too long.Patient said if they move a certain way they get pain.Patient asked if this was normal, patient informed that pain started since the implant date, they mentioned that they could feel the implant.They mentioned that they had a follow up appt today but it was canceled.The patient was redirected to their healthcare provider to further address the issue.Patient asked if they can go to waterslides and swim.Patient provided with information.Redirected to hcp for implant site/healing concern.
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Search Alerts/Recalls
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