MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Urinary Retention (2119); Insufficient Information (4580)
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Event Date 04/14/2024 |
Event Type
Injury
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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 urge incontinence, urinary/bowel dysfunction.It was reported that their bladder would not work at all with the therapy on, and they couldn't urinate at all.The patient stated that they notified their representative.Patient requested that agent switch rep for the patient.Agent reviewed the patient could consider a different healthcare provider and voice their concerns to hcp.The patient stated they have an appointment with oxford urology on monday in order to get in soon due to their pain, and are trying a new healthcare provider.Agent emailed physician listings to the patient and reviewed pats role.
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Search Alerts/Recalls
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