MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problem
Electromagnetic Interference (1194)
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Patient Problem
Incontinence (1928)
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Event Date 03/18/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3: date is approximate.Month and year are confirmed 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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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 patient had an mri about three weeks ago.They undid it for the mri and reprogrammed it.Patient has been having excessive accidents since then.Patient doesn't think they put it back to the right spot.Yesterday they had three accidents, one right after the other.Patient never had that many but has had several since the mri.The issue started about a week to a week and a half ago.Patient thought they were at 1.9 ma but they are currently at.9ma.Agent told patient they could try increasing the stimulation as long as it was comfortable and see if that helps.Also suggested they could try calling doctor's office to see if they have their amplitude in their records.
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Event Description
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Additional information was received from the patient.They reported that the issue was not resolved.
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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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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