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); Charging Problem (2892)
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Patient Problems
Burn(s) (1757); Burning Sensation (2146)
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Event Date 06/13/2022 |
Event Type
malfunction
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins).The reason for call was the recharger that they put on their back was getting very hot and burned their skin (patient services (pss) asked multiple times if a mark was left or if it was a burning sensation; the patient (pt) said it was getting very hot and they could not tell if it left a mark on their back side).The recharger (rtm) cord that connected to the antenna was burning their back and so was the relay box, it was getting hot to the touch.Pt said the burning started this morning and now it won't charge the implant even when they moved it from one place to the next.A replacement recharger (rtm) was sent out to the patient.
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Manufacturer Narrative
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Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4).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.
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Manufacturer Narrative
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Continuation of d10: product id 97755 serial# (b)(6) product type recharger h3.Analysis found that the recharge antenna failed due to a "no device found" message.The recharger cable insulation was peeling away at the recharge antenna end with exposed wires, and 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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