MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
High impedance (1291); Unintended Collision (1429); Energy Output Problem (1431)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2019, other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 31-jul-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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It was reported that patient had a fall sometime before (b)(6) 2021 and experienced increase in therapy intensity.Impedances were run and all 16 contacts were either out of range or very high.It was decided to turn off therapy for now.Caller went to surgical consult with patient to get issue addressed.Imaging was done over lead and ins but nothing was conclusive as far as damage or connection issue.The caller was not with the patient.Patient will see hcp for next steps and surgical intervention.
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Event Description
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Additional information rec'd.Patient responded from follow up sent.Patient reported cause of fall was patient was running to bathroom and tripped on their feet.Patient met with rep, and they tried everything possible to get unit to help patient's pain.Hcp will be putting in a new device (b)(6) 2021.
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Manufacturer Narrative
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Continuation of d10: product id 977c165, serial# (b)(6), implanted: (b)(6) 2019, explanted: 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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