MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problem
Overheating of Device (1437)
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Patient Problem
Burn(s) (1757)
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Event Date 05/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 97755 lot# serial# (b)(4) implanted: explanted: product type recharger.Information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: nlf040437n, ubd: , udi#: (b)(4).Is year valid.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 (pt) who was implanted with an implantable neurostimulator (ins) for rsd/causalgia-complex regional pain syn and non-malignant pain.It was reported that the pt has 2 inss.Pt called about the ins on the right side implanted for her legs (97715).The ins on the left side was for her hands.The pt reported that her ins battery gets really hot and burns her when charging in the last month or so when she has the paddle piece over it.It starts charging ok and all of a sudden it turns red and burns her skin.The ins battery itself burns from the recharging paddle piece.Pt got to the point where she could not take it.Recharger looks ok, it is not damaged.Pt said she did not get any burning marks on the skin.Pt mentioned she was scheduled to see the rep on (b)(6) at her rsd healthcare provider.Pt also thought she had one ins that would last 4 years and the other one 9 years.Reviewed the longevity/eri/eos of both inss.Pt then was hard to understand, did not catch whether she said 'paying for surgeries' or 'painful' surgery.
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Manufacturer Narrative
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Continuation of d10: product id 97755, serial# (b)(6), explanted: product type recharger, h3.Analysis found the complaint was unverified.Recharger never got hot after running it for 10 minutes.H6.Evaluation result code 3221 does not apply.Evaluation method code 4114 does not apply.Evaluation conclusion code 67 does not apply.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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