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); Communication or Transmission Problem (2896)
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Patient Problems
Erythema (1840); Pain (1994); Burning Sensation (2146); Discomfort (2330)
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Event Date 05/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 97755, serial# (b)(4), product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot #: (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.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 who was implanted with an implantable neurostimulator (ins) for unknown indications for use.The reason for call was the patient (pt) reported when they charge their neurostimulator (ins) battery their back and their recharger gets really, really hot where it feels like their flesh is burning inside out.Pt said it aches/hurts so they have to take the recharging antenna (rtm) pad off and wait until it cools down then charge again.Pt commented they can't take hot showers b/c they have the achy/burning/pain feeling where ins battery is implanted.Pt denied any blistering/flesh damage; pt any flesh damages just redness/ hot to the touch.Pt stated the ins always heats up now when recharging which began probably three months ago with it getting progressively worse.Pt added if they are walking a lot they get the achiness /tenderness where ins is located from the heat.It was also noted the pt reported the recharging antenna (rtm) has not been charging properly since probably 3 months ago.Pt stated they are while to mess with rtm 20-30 minutes in order to find the neurostimulator (ins).Pt described rtm not advancing from passive recharge mode.A new recharger was requested.
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Manufacturer Narrative
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Continuation of d10: product id 97755 lot# serial# (b)(6).Type recharger h3.Analysis found that the complaint was unable to be verified and the recharger passed all tests.Scratch marks were observed on the recharge antenna.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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