MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 353101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id neu_unknown_lead lot# unknown serial# implanted: (b)(6) 2024 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, 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 reported that their trial began on (b)(6) 2024.It was reported that there was a suspected infection.There is no redness, but there is "quite a bit of pain" at the incision site.Patient described the pain as a 3 or 4 on a scale of 1-10.Patient is not sure if the pain is caused by an infection or something else.Overall they feel "yucky" inside.
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Event Description
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Additional information was received from a healthcare professional (hcp).The hcp reported that the mdt device or therapy was not a contributory factor of the infection.
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Manufacturer Narrative
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Continuation of d10: product id neu_unknown_lead lot# unknown implanted: (b)(6) 2024 product type lead.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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