MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number NEU_INS_STIMULATOR |
Device Problems
Electromagnetic Interference (1194); High impedance (1291); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Fatigue (1849); Anxiety (2328); Ambulation Difficulties (2544); Electric Shock (2554); Paresthesia (4421)
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Event Date 10/13/2021 |
Event Type
malfunction
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Event Description
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It was reported that the patient had an open circuit, which was found in (b)(6) 2021.The patient also reported that he recently had tingling by his collar bone, which may be related to the open circuit.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a patient.It was reported that the patient has also experienced balance issues, and increased anxiety.The patient also experience electric shocks.The patient stated that they experienced a couple 'small traumatic experiences' around the time the issue began.They got in a small car accident, and had an mri performed in which the mri tech stated 'it was getting a little warm', the patient did not know what they meant by that.The patient also stated they felt drowsy.A ct scan did not show any breaks in the wires.
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Search Alerts/Recalls
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