MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
|
Back to Search Results |
|
Model Number NEU_INS_STIMULATOR |
Device Problems
Electromagnetic Compatibility Problem (2927); Patient Device Interaction Problem (4001)
|
Patient Problems
Device Overstimulation of Tissue (1991); Insufficient Information (4580)
|
Event Date 10/19/2022 |
Event Type
malfunction
|
Event Description
|
Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins).Caller reports patient had sympathetic block injected into the epidural space about 8-10ml lidocaine with steroid mix.Caller reports patient was laying on the table and feels fine prior to injection.Caller reports after the injection, patient felt the stimulation setting went super high and was contracting, like the stimulation was too much.Caller reports patient did not bring his controller.Caller reports the clinic did not check the stimulator.Caller reports after patient was sat up, patient was under anesthesia, patient's leg was flirting, hcp believes it was from the stimulation.Patient indicated the stimulation was high, high.Caller reports as soon as patient was sat up, the overstimulation went away.Caller reports before patient went home, patient lay down and up, patient felt fine, no overstimulation.Caller reports since patient has been home, patient have not called the clinic to report any issue.Caller do not know if adaptive stim was programmed on.Caller have not met the patient; caller will see patient tomorrow.Caller do not have patient information, email sent.Redirect caller to medication injection to hcp.Reviewed checking impedance, reviewed if needle puncture any of the lead insulation.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Additional information was received.It was reported that the cause was not identified.The patient was moved into an upright position, and the overstimulation was resolved.Patient was seen and did not have any impedance issues upon interrogation.
|
|
Manufacturer Narrative
|
G4: a correction was made to include pma.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.
|
|
Search Alerts/Recalls
|
|
|