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); Device Overstimulation of Tissue (1991); Discomfort (2330)
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Event Date 03/04/2024 |
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 dysfunction/sacral nerve stim.The reason for call was the patient(pt) said after implant they were so grateful that ins was working to help their symptoms until march 4 when they were hit in their back on their right cheek people and kneed in the same place.Pt said, that afternoon, bad bladder leakage started and that night, they had symptom return, during the night.Pt said their back is real sore and when therapy is turned on their rectum feels like there is an electrical charge it in.Pt said they turned therapy down and it still happened and they turned it off and left it off for 6 hours.The feeling in their rectum stopped when it was off.Pt said they turned it back on, but it is still not working as well as it was.Pt said they think their symptoms are gradually getting better now, last night they wore just a small pad with little drips.Redirect to hcp.
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