MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number NEU_INS_STIMULATOR |
Device Problem
Electromagnetic Interference (1194)
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Patient Problems
Pain (1994); Insufficient Information (4580)
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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 the patient had eye surgery about 4 years ago and was in so much pain.Patient stated that is because "he did not put me out" and patient did not turn off their implantable neurostimulator (ins) and cautery was used.Patient stated pain was in head, right side of face, right eye and the lead was located on the same side.Patient stated telling the doctor to stop and was sliding off the chair.Additional information was received.Information was repeated regarding the pain they were in when they had eye surgery "maybe 6 years ago." the patient added that the same thing happened last week, but they did not specify what happened.The patient stated the surgeon was going to potentially do surgery on the patient's right eye, and the patient told the surgeon that patient services had reviewed cautery guidelines (which included turning off therapy).The patient said they called their neurologist, but never got a return phone call.The patient stated that the eye surgery was put on hold.The patient mentioned that they had an appointment on friday, and their doctor asked the patient how they would turn off therapy, but the patient only knew how to sync the programmer with the ins.No further information was provided.
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Search Alerts/Recalls
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