MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Failure to Deliver Energy (1211); Energy Output Problem (1431)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 03/01/2022 |
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 patient who was implanted with an implantable neurostimulator (ins).The reason for call was patient reported for about 3 weeks the controller keeps not working and have to reset controller because of black screen.Patient reported sometime stimulation goes off by itself and sometimes, at night, there is over stimulation on one wire and they have to adjust the stimulations, various things happens and controller gone blank and stops working.Patient services (ps) asked patient if the controller went blank when recharging the ins and patient said no, only when using the controller to do various things.Ps assisted patient with resetting the controller.After resetting the controller power on, screen shows controller 100%, ins 70% charged.The patient was sent out a replacement controller.
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Event Description
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Additional information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins).The patient (pt) reported there were no circumstances that led to the stimulation turning off on its own and being too high; the patient stated they were "just leading their life".There were no steps taken, they would just turn it back to the correct stimulation.When it went out completely, they removed the battery (understood as controller battery).The patient was asked if the issue resolved, they said "hopefully".
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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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