MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
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Patient Problem
Electric Shock (2554)
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Event Date 06/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 implantable neurostimulator (ins).The reason for call was pt reported feeling a shocking like sensation in the diaphragm area when the pt laughs or is in certain positions.Pt mentioned they have stimulation programming set so they don't feel the stimulation (high dose).Pt reported the issue occurred a little bit the last couple weeks and has gradually gotten worse.Pt reported decreasing stimulation and continued to experience the issue.Pt stated the sensation goes away if the stimulation is turned off.Pt reported no falls or trauma.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.Pt clarified the stimulator is for nerve pain/sciatic pain in the legs, greater in the left.
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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.
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Event Description
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Additional information was received from the patient.The patient reported that they were told it was due to normal change from healing, scar tissue, etc.Also from jolts from coughing, sneezing, laughing, etc.The patient reported that they were trying to adjust program 1 only down to 1.1 instead of the other programs at 1.3.The patient reported that the change seemed to help although they have not had a heavy laugh yet since the program change.The patient noted that it was good to find out to know that this was normal and there were no problems with the wires or unit.
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