MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number B35200 |
Device Problems
Therapy Delivered to Incorrect Body Area (1508); Electromagnetic Compatibility Problem (2927)
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Patient Problems
Undesired Nerve Stimulation (1980); Insufficient Information (4580)
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Event Date 05/08/2023 |
Event Type
malfunction
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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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It was reported that they had a facial yesterday and they hadn't realized there had been radio waves used.The caller inquired about if that would affect the deep brain stimulation device.Patient services (pss) reviewed.The caller stated there had not been any heat during the facial, just that the equipment worked to suck juice/liquid off of their face.The caller stated they had a little bit of a change in therapy they noticed yesterday and today.The caller further described that yesterday when they got home, they had washed their face as they could feel it on their face, but the slight change in stimulation they were experiencing was not a lot where the effect was not really strong, just that they seemed to have had a slight change, and that they were more "doggish" today.Pss reviewed for future, healthcare provider (hcp) could contact technical services for guidelines/considerations based on equipment/procedures.Pss redirected patient to their healthcare provider to further address what they were experiencing.Caller stated they had an appointment with their follow-up hcp on the 25th, and would go in earlier if they felt the need to.
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Search Alerts/Recalls
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