MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Pocket Stimulation (1463); Therapy Delivered to Incorrect Body Area (1508); Patient Device Interaction Problem (4001)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 01/09/2024 |
Event Type
malfunction
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Manufacturer Narrative
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G2: belize.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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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient was having issues with their stimulation and the issue began about 3 weeks ago.Patient would try groups a, b, and c and would increase or decrease stimulation but they were not getting relief.Every now and then if the patient sneezed, coughed, or moved a certain way, would get stimulation in the implant area.Patient would also get stimulation in other places but every now and then they would feel stimulation on the implant site.The patient was currently in belize traveling and would like to get the device reprogrammed.
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Search Alerts/Recalls
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