MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97716 |
Device Problems
High impedance (1291); Low impedance (2285)
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Patient Problem
Pain (1994)
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Event Date 07/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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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Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins).It was reported that there were high and low impedances.5: 17970, 6: 17720, 7: 40000, 8: 1410, 9: 1410. patient states return of pain.Patient states stimulator not helping in painful areas.Asked but unknown when impedance issue occurred.Rep mapped on lead and programmed ld around impedances.Rep as able to give patient a,b,c ld options.The issue is ongoing.The manufacturer representative (rep) indicated they would send any further information as they become aware.Additional information was received from the manufacturer representative (rep).It was reported that effective therapy was able to be established with reprogramming. .
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Search Alerts/Recalls
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