MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Electromagnetic Interference (1194); Migration or Expulsion of Device (1395)
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Patient Problems
Pain (1994); Burning Sensation (2146)
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Event Date 07/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 977a260, serial#: (b)(6), implanted: (b)(6) 2020, product type: lead; product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #:(b)(4), ubd: 19-mar-2023, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(4), ubd: 19-mar-2023, udi#: (b)(4).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 manufacturer representative, regarding a patient who was implanted with a neurostimulator (ins).It was reported that patient had an mri last week and during the mri had a warm burning sensation in his back.They stopped the mri and the pain slowly resided.Since then the stimulator has not worked.The patient claimed that he had the device in mri mode.The rep met with the patient on 7/7 and they ran impedances and they were within normal ranges.The md took an x-ray which showed that the leads migrated downward.The rep changed the therapy parameters and the patient was going to use stimulation and will follow up with the rep.No further complications were reported.
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Event Description
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Additional information was received from the rep.It was reported that the warm/burning sensation was in the back in general.Patient's weight was unknown.After changing the parameters, patient says they still have very little vm pain left.
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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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