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); Patient Device Interaction Problem (4001)
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Patient Problems
Itching Sensation (1943); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994)
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Event Date 12/28/2021 |
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) for spinal pain.It was reported that patient asked about ct-scan, xray, ultrasound, dental, mri and mammogram.Ps reviewed information and if hcp ofc have questions they could call mdt.Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was patient reported she is having concerns about her therapy.Patient reported since getting the implant when she sits back she felt the stimulation real strong in the legs and all of a sudden that sensation stopped yesterday and she is wondering if something is wrong.Patient reported yesterday when she leaned back she didn't feel the intense stimulation in her legs, that feeling is gone.Patient reported a month ago the back of her left leg was real itchy and that's where she have rsd to the feet and leg.Ps assisted patient with checking adaptive stim feature and there is no adaptive stim enabled.Setting are group a, p1 @3.0v, p2 @3.0v controller showed ins 90%, controller 90% charged.Ps confirmed therapy is helping patient.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.Patent lives in (b)(6) for the winter.Ps reviewed ps role.Ps confirmed patient did not have fall or trauma.Patient stated just everyday living.
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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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The patient reported that there has been no changes yet in therapy.The patient reported that they might need changes in therapy because some of the pain is returning in their left leg and lower back.The physician is planning to contact a manufacturer representative to help possibly adjust the settings for their implant.
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Search Alerts/Recalls
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