MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 353101 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Itching Sensation (1943); Urinary Retention (2119); Swelling/ Edema (4577)
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Event Date 12/16/2023 |
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 urge incontinence.It was noted that the patient's trial started on (b)(6) 2023.It was reported that the patient was itchy.Additional information was received on (b)(6) 2023, patient reported that their leads had become disconnected.Additional information was received from the patient.During a post evaluation call, the patient mentioned that they did not wish to proceed with the implant as during their trial their legs became extremely swollen and they were unable to urinate.This was resolved upon removal of device.
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