MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Energy Output Problem (1431); Data Problem (3196)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/01/2020 |
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 and manufacturing representative (rep) regarding the patient's implantable neurostimulator (ins).Information was reported that the patient called the rep and stated their stimulation has been going to zero automatically.The rep met with the patient, and the patient stated that his system had switched to group b from group a randomly a couple weeks ago.He just realized that he wasn't on group a few days ago so he switched back.When he did, his intensities were all 0.0 for each position.The rep checked the orientation of his battery and everything was accurate.The rep reoriented the ins just to be safe and assigned intensities to each position on group a.The patient was educated on stability time for when he makes changes and the patient verbalized understanding.It is unknown exactly as to why his intensities weren't saved after making adjustments, but the patient was not experiencing any issues with their patient programmer at the conclusion of the meeting.
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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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Additional information was received.It was reported the patient still experienced stimulation changing intensity to 0.0 randomly.The patient did not have a journal of when the incidents happened and could not recall any rhyme or reason to them.The patients diaries were looked into and they did not have an intensity assigned to every position.Therefore, the patient was assigned an intensity to each position.The patient was instructed to see if they noticed whether it continued to switch to 0.0 and to keep a journal of when it did and what they were doing at the time.
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