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
Stroke/CVA (1770); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
Injury
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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 and urgency frequency.It was reported that their trial began on (b)(6) 2024.It was reported that patient's husband answered support links call.They stated the patient was unavailable as they were laying in a hospital bed.He did not give any details. patient stated that they had to call 911 and had an emergency.They stated that they had a stroke.Patient stated they have turned off their therapy as they do not know if it is the device or not.
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Manufacturer Narrative
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B3: date is estimated; month and year are valid.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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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 or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements stipulated in 21 cfr 803.H.6.Codes have been updated to reflect the new information.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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Additional information was received from a healthcare professional (hcp).The hcp reported that the medtronic device/therapy/procedure was not causal or contributory with respect to their hospitalization and/or stroke.They noted the steps taken/will be taken as "ongoing care with patient's internist".It was unknown to the hcp if the issue was resolved.
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Search Alerts/Recalls
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