MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Overheating of Device (1437); Delayed Charge Time (2586); Battery Problem (2885); Insufficient Information (3190)
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Patient Problems
Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Date is approximate.Month and year are confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name intellis; product id 97755-s (b)(6); product type: 0213 recharger.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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It was reported that information was received from a patient regarding an external device.The reason for call was patient stated the controller was not working right and every time they used the paddle that the paddle was getting hot.Patient worked with the medtronic rep to troubleshoot and was instructed to reset their controller.Patient took a picture of the system problem rm03 message and sent it to the rep who instructed to call patient services (ps).Agent asked patient to inspect the recharger for damage and patient noted no physical damage to the recharger but was not acting right like it used to.Patient mentioned it took them 2.5 hours to charge their implanted neurostimulator (ins) and sometimes it took half an hour.Patient noted the implant went all the way down to nothing and patient was wondering why they were in so much pain needing some relief.The issue was not resolved.An email was sent to the repair department to replace the recharger.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Product id 97755-s lot# serial# (b)(6) product type recharger medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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