MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Unintended Collision (1429); Energy Output Problem (1431)
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Patient Problems
Dysuria (2684); Insufficient Information (4580)
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Event Date 03/01/2024 |
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 had a fall on march 1st 2024 and since then has had a return of bladder issues.Reviewed changing programs or increasing stim and contacting hcp.Caller did not currently have a managing hcp and may contact their pcp.
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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 the patient.The reason for the call was that the patient reported that maybe a month ago they noticed they did not think their stimulator was working because they were having to push to pee.I offered to assist pt to use their equipment to try and check their settings, and pt tried several times to synch with their ins but was not successful.They restarted their handset and communicator and tried again, but it was not successful.Eventually, it was determined that they had a j3 handset and were not using equipment for their current ins.The patient reported that they don't know if they ever got control equipment for their current implant or if it was lost/stolen.They reviewed some brief information on interstim therapy optimization and how to replace lost equipment and were redirected to their doctor to further address the issue.Redirected to their healthcare provider.The issue was not resolved through troubleshooting.
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Search Alerts/Recalls
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