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); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Burning Sensation (2146); Insufficient Information (4580)
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Event Date 12/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B3: date is approximate.Month and year are confirmed valid.B3: event date is not known.Please see b5 for approximate date range, if applicable.Section d references the main component of the system.Other medical products in use during the event include: brand name intellis; product id 97755 (serial: ((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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Information was received from a patient's representative regarding an implantable neurostimulator (ins). caller reported the patient has had pain around the implant site where battery is located for 2-3 months which started on it own.Caller states the patient has lost weight and the healthcare professional (hcp) thought maybe that is part of this all.Pt has been in touch with hcp about this.Agent reported event. caller states they went to the hcp today because of pain around ins location and that the charging is taking forever to charge and its heating up.Caller states they turned off so didn't have to charge because it got so bad.The issue was not resolved through troubleshooting.An email was sent to the repair department. .
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Manufacturer Narrative
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Concomitant medical product: product id 97755, 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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