MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)
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Patient Problem
Electric Shock (2554)
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Event Date 09/01/2020 |
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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Pt said he just turned ins back on since the weather's gotten colder (said he could tolerate the pain when it is warm out) "the other night" (confirmed this month) and his stimulation was set at "3" on group b when he was woken up by the stimulation "knocking the crap out of me", "shocking me, you know hitting me hard".Pt said the stimulation had gone up to 6.2 or 7.2 on its own.He said it has done that 2-3-4 times until he turned it off and put it on a different program.Patient services asked, and pt did not know if he had adaptive stimulation (as) programmed in.The pt was unable to check during the call.Pt was redirected to follow up with their health care provider (hcp).
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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 reported that the cause of the shocking was not determined.The patient met with a manufacturing representative (rep), and the patient noted that they are hoping that the shocking has been resolved.
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Search Alerts/Recalls
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