MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problem
Data Problem (3196)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: event date is an estimate (year valid).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 consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient was having problems with the controller as the controller was switching programs by itself.The patient stated they turn adaptivestim off since it doesn¿t work well for them, so they will have stimulation set to group b, and the controller switches it to group c on its own even after it had been locked.The controller states to 'call mdt' and then shuts down while they are trying to recharge the ins, so they have to reset the controller to get it to work again.While recharging the ins, the controller initially flashes green but then it flashes yellow instead, and it was taking a long time to recharge the ins.A replacement controller was sent to the patient.No impact to the patient or their symptoms were reported.
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Event Description
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Additional information received from the consumer.There were no changes that led to the settings changing by itself.The controller changed randomly on its own.Nothing worked to resolve the issue.The replacement controller works fine.
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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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