MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
Unintended Collision (1429); Insufficient Information (3190)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/25/2024 |
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 gastrointestinal/pelvic floor therapy and urinary dysfunction/sacral nerve stim.It was reported that they were thrown off their horse on monday and since then they have been having issues with their ins.Caller stated that they turned on their handset and are trying to connect to their implanted neurostimulators and they are getting a notification that account action required needs to be done before they can connect.Patient service specialist conferenced on hit agent who reviewed notification with patient.Patient stated they have been having "ic" issues again since monday.Patient stated their hcp is ordering them an x-ray.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.
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Search Alerts/Recalls
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