MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97714 |
Device Problems
Energy Output Problem (1431); Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892)
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Patient Problems
Burning Sensation (2146); Alteration in Body Temperature (4568)
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Event Date 05/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 who was implanted with an implantable neurostimulator (ins) for non-malignant pain.The patient said that starting about a month ago, they had been needing to recharge their ins more often, the ins started to feel really warm in their skin (if they put their hand on their skin they can feel it warming up), the ins charge doesn't hold, and they don't feel the leads giving off as much stimulation anymore.Pt said sometimes their ins charge would last all day and sometimes would only last a few hours and when they recharge, the ins feels like it was burning them.
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Event Description
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Additional information was obtained on november 24, 2021.The patient reported that the cause of the frequent recharging was likely due to their settings and usage because they were using their device 24/7.The ins was replaced on (b)(6) 2021 due to the burning sensation and the recharging issues they were having.The burning sensation and the recharging issues resolved after the ins was replaced.Patient weight was provided.The patient redirected us to contact the rep to determine what was done with the explanted ins.The rep reported the ins was discarded by the scrub tech after the case was completed.
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Manufacturer Narrative
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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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