MEDTRONIC NEUROMODULATION NURO; STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION
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Model Number 3533 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Urinary Tract Infection (2120)
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Event Date 09/26/2017 |
Event Type
Injury
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Event Description
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The patient reported that they currently had a bladder infection, so they were leaking more at the time of the report.It was indicated that this started since beginning the percutaneous tibial neuromodulation (ptnm) therapy.They stated that they have had bladder infections before.It was noted that the patient was currently on antibiotics, and was getting better.They had completed 8 sessions.There were no further complications reported as a result of this event.
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Manufacturer Narrative
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Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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