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
Urinary Retention (2119); Insufficient Information (4580)
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Event Date 04/05/2024 |
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 representative and a patient who was implanted with an implantable neurostimulator (ins) for urge incontinence and urinary/bowel dysfunction.It was reported that the patient was experiencing worsening baseline symptoms of non-obstructive urinary retention.It is unknown if the issue was resolved.The patient representative reported that the patient was having a hard time going to the bathroom and the issue began last friday when patient was implanted (b)(6) 2024.Caller inquired if they should adjust the program.Agent asked if they already discussed the symptoms with their doctor and caller stated no.Finally, patient stated "let me call you back, ok" and disconnected.Agent attempted to call caller back to obtain additional information due to caller disconnecting the call but was not able to be obtained.
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Search Alerts/Recalls
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