Model Number 3116 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
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Patient Problems
Sleep Dysfunction (2517); Electric Shock (2554)
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Event Date 02/20/2018 |
Event Type
malfunction
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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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Event Description
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Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported when she laid on her right side, she got a shocking feeling on her left side where the probes went into her stomach.The patient noted she could not lay and sleep on her right side.The patient stated it was not like that when she first had it.The patient stated it used to happen every so often and now it was like every day, so it was progressively gotten worse.The patient was wondering what could cause that and what course of action she needed to take to resolve.The patient stated she had an x-ray a while ago, but she was sitting straight up, and they said the wire was where it was supposed to be.There was no trauma, falls, or medical procedures that she thought would be related to the issue.It was noted the event began about a year prior to the report.There were no further complications that have been reported as a result of this event.
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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 consumer.It was reported that the patient rolled to their other side and changed position to resolve the shocking.It was noted that the shocking happened when the patient was on their right side and occasionally when sitting up.No further complications were reported/anticipated.
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Search Alerts/Recalls
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