MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number B35200 |
Device Problem
Electromagnetic Interference (1194)
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Patient Problems
Headache (1880); Burning Sensation (2146)
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Event Type
malfunction
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Event Description
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It was reported that in the past, the patient had an mri done with the dbs turned off, and when the mri was done, the patient had a headache and felt burning sensations.They met with the neurologist and had a ct performed.The caller stated they did not know what was going on with the patient's dbs and they were worried.When asked event date details, the caller stated they were not sure and this was the patient's first time for a pre-op visit as the last time, the patient had an emergency procedure on their gallbladder and the caller was not present.They stated the neurologist sent their physician assistant who had the ipad and they were not sure what they saw or experienced or if something different happened for them when they turned the patient's ins off.
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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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