Model Number 37800 |
Device Problems
Intermittent Continuity (1121); Insufficient Information (3190)
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Patient Problems
Eructate (1839); Nausea (1970); Pain (1994); Insufficient Information (4580)
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Event Date 10/06/2020 |
Event Type
malfunction
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that for the past 2 years the patients (pt) device feels like a tens unit inside of them periodically.The healthcare provider (hcp) has tried to decrease the voltage but it does not help.The caller indicates that the device is still working to control the symptoms, they still sometimes get full fast, belch, and get nauseated, but the therapy still works.The caller states that the intermittent sensations sometimes happens when using abdominal muscles, bending over or laughing or driving.The caller also described the sensations as a pulling feeling or electrical sensation, throbbing, pulsating.The caller went to the er and did not tell them about their implanted device, they did an ekg and wrote on the patient's paperwork: "suspect pacemaker failure".Reviewed ekg guidance.Reviewed that the device is not designed to have to be uncomfortable or painful to work.The patient was redirected to their healthcare provider to further address the issue.
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Manufacturer Narrative
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Event date is estimated.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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Search Alerts/Recalls
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