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 Problems
Burn(s) (1757); Pain (1994); Burning Sensation (2146)
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Event Date 05/12/2022 |
Event Type
malfunction
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Event Description
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Information was received from a patient (pt) regarding an external device to an implantable neurostimulator (ins).It was reported that the pt's recharger was getting hot and left a red mark on their skin.Pt said they would take the recharger off of their skin before it blisters.Pt said they hadn't been able to recharge and were in a lot of pain.Pt also noticed that their ins was getting hot while recharging.A replacement recharger was sent out.Pt will try and use the recharger replacement; however, if that does not resolve their issue, pt will follow up with hcp for further assistance.
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Manufacturer Narrative
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Concomitant medical products: product id: 97755, lot #: na, serial #: unknown, implanted: na, explanted: na, product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot #: unknown, ubd: na, udi #: na.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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Manufacturer Narrative
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Continuation of d10: product id 97745fa lot# serial# (b)(6) implanted: explanted: product type programmer, patient product id 97755 lot# serial# (b)(6) implanted: explanted: product type recharger h3.Analysis found that the recharger cable insulation was pulled from the recharge antenna with broken and exposed wires.The recharger was subsequently scrapped.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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