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); Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Burn(s) (1757); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 97745, serial#: (b)(4), product type: programmer, patient; product id: 97755, serial#: (b)(4), product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4).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.It was reported that the reason for call was pt got "software problem: cannot continue: call medtronic: 1_intellis 2_ 3.0 3_0 4_'nothing'" when the pt was charging their implanted neurostimulator(ins) today.During the call, the pt performed a hard reset on the controller and removed the software problem message.The pt then initiated a charging session of the ins and got recharging "excellent." ins charge was at 40% and controller charge was at 60%.The troubleshooting steps that were taken on the call resolved the issue.Pt had been taken off all of their pain medication in preparation for an upcoming surgery.Pt mentioned they had two previous ins replaced due to normal battery depletion.Additional information was received from a patient (pt) regarding an external device.The reason for call was pt reported that they have been seeing "rm04" messages appearing on their controller while charging their implant.Pt said this happens 2 to 3 times a day and resetting the controller doesn't resolve the issue.Pt said that they contacted ps about this a month ago about the rm04 message appearing and they were told to reset the controller; pss understood pt was confusing the "rm04" message with the "software problem" message they were seeing a about a month ago.Pt also said that the recharger antenna cord is gets really hot by where the cord meets the paddle.Pt said that they have been shocked and physically burned.Pt also said that the relay box on the cord gets really hot.Pt said this has all been within the last week and a half.An email was sent to the repair department to replace the recharger antenna.Pt said they have upcoming back surgery on the 19th and right now the only thing that they use for pain relief is the scs.Pt said they were taken off pain meds in september and the pain started in october and they hope the upcoming back surgery resolves this.
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Manufacturer Narrative
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H3: product id 97755, sn# (b)(6), was returned for product analysis.Analysis found there was a recharger telemetry module (rtm) failure, the "no device found" message was seen and the device was scrapped due to failing on bench testing but passed at plexus.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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