MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Display or Visual Feedback Problem (1184); Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: product id 97755-s lot# serial# (b)(6): product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 97755-s, serial/lot #: (b)(6) h3: analysis of the 97755-s recharger (s/n (b)(6)) revealed that controller won't power on when rtm is plugged in.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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 (pt) regarding an external device. the reason for call was pt reported issues while recharging the implant for a week and a half now.Pt said the controller kept saying low battery when the controller was full, and now pt was getting no device found with implant battery 50% or charging would start and stop.Pt mentioned they had tried resetting controller.Pt checked for damage to recharger (rtm) and controller (didn't see any), reset controller, and cleaned connections.Pt unlocked controller without rtm and reported controller battery 80%, implant 70%.Pt then tried to start a recharge session and was on checking the recharger for a while, then rm05 came up.Pt mentioned they'd had so many problems.The issue was not resolved. pt says they got the new controller repair sent but when they get to the screen that says connect the recharger it doesn't recognize when their rtm is plugged in.They said once they got it to recognize the rtm being plugged in, but it went back to the "replace controller ba ttery" screen, which is the reason we sent the new controller.Pt says they have "been suffering" while having to wait for the new controller to come, and said "now i have to suffer again until tomorrow when this one comes".
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