MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Migration or Expulsion of Device (1395); Unintended Collision (1429)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 977a260, serial#: (b)(4), product type: lead.Product id: 977a260, serial#: (b)(4), product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 22-mar-2023, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 22-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 the consumer regarding a patient who was implanted with a neurostimulator for spinal cord stimulation.It was reported that the patient fell a month and a half ago and was not needing to get a revision done.Patient stated they believed the wires fell because of the fall.Patient stated they tried reprogramming the device but that did not do the job.
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Event Description
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Additional information was received from a consumer.It was reported that the device revision took place on (b)(6) 2020.The patient stated that the lead falling was due to the patient's fall on their back.The issue was reportedly resolved.
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Manufacturer Narrative
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Concomitant medical products: product id 977a260 lot# serial# (b)(6) product type lead product id 977a260 lot# serial# (b)(6) 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.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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