MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
High impedance (1291); Energy Output Problem (1431); Impedance Problem (2950); Patient Device Interaction Problem (4001)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 06/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: date inaccurate, only the year is valid.Concomitant medical products: product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 14-nov-2022, 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 an implantable neurostimulator (ins) for non-malignant pain.It was reported that the representative met with the patient regarding a therapy issue.The patient was fishing and thought something changed.The 8-15 electrodes were out of range (the value was unknown).The patient was to be scheduled for a lead revision in january.The patient was on evolve workflow so they did not feel a therapy change and they reported that it was working great prior to the fishing event.
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Manufacturer Narrative
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Continuation of d10: product id 977c165 lot# serial# (b)(6) implanted: (b)(6) 2019: product type lead.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 impedance values were high and out of range.The exact cause of the impedance issues was not determined; however, a surgical intervention has been scheduled for b)(6) 2021.
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Search Alerts/Recalls
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