MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 353101 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problems
Micturition Urgency (1871); Urinary Retention (2119); Urinary Frequency (2275); Insufficient Information (4580)
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Event Date 03/20/2024 |
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 trial patient who was using an external neurostimulator (ens) for non-obstructive urinary retention and urgency frequency.It was noted that the patient's trial started on (b)(6) 2024.It was reported that the patient was experiencing a communication issue between the controller and ens.They had intermittent, difficult, or sporadic communications.It was unknown if troubleshooting was performed.The cause was not known.They also had a worsening of their baseline symptoms of non-obstructive urinary retention and urgency frequency.It was unknown if the issue had been resolved.
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Search Alerts/Recalls
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