MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2023 |
Event Type
malfunction
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Event Description
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Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was patient stated that when they first got the implant, they were charging every day.Patient said now the implant battery had only gone down 10% since they charged yesterday and when they went to charge, the controller said stimulation was off.During the call, patient service specialist walked patient through turning stimulation on, pt confirmed green box around group a.Pt said they had already turned stimulation back on, and that they thought they had done that the other day when the implant was at 80%.Patient said the stimulation had been turning off on its own for about a week and a half, and it took forever for the implant battery to go down so they noticed the issue was persistent.The patient was redirected to their healthcare provider to further address the issue if issue persisted; agent explained a medtronic rep should meet with them to interrogate ins and possibly reprogram ins.
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Manufacturer Narrative
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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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