MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Energy Output Problem (1431); Low impedance (2285)
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Patient Problems
Device Overstimulation of Tissue (1991); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2023 |
Event Type
Injury
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Event Description
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Information was received from multiple sources (healthcare provider, clinical study, manufacturer representative) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient had good stimulation on his leg but experienced overstimulation on his ankle, and gave him pain to his abdomen and thorax.Etiology was probably related to the device or therapy.The device was reprogrammed many times.Imaging was taken to see if the lead moved.An additional lead was implanted on (b)(6) 2023.After the connection of the second lead to the device, plot 8 and 10 had low impedance but these plots were not used.Etiology for the low impedance was possibly related to the device or therapy.The patient does not feel anything strange so no more action was needed.The outcome was resolved without sequelae on 2023-oct-19.
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Manufacturer Narrative
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Continuation of d10: product id 977a290 lot# va29hrr030.Implanted: (b)(6) 2020.Product type lead product id 977a290 lot# va2q6nz013.Implanted: (b)(6) 2023.Product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(6), ubd: 30-sep-2024, udi#: (b)(4) ; product id: 977a290, serial/lot #: (b)(6), ubd: 28-nov-2026, udi#: (b)(4).H6 codes belong to the leads.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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Manufacturer Narrative
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Continuation of d10: product id 977a290 lot# va29hrr030, implanted: (b)(6) 2020, product type lead, product id 977a290 lot# va2q6nz013, implanted: (b)(6) 2023, product type :lead, g2.Foreign: (b)(6).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.Regarding if the low impedances were consider out of range, it was stated that between the plot 8 and 10 plot, under 1000 of impedance on the print telemetry.
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Search Alerts/Recalls
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