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 07/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Report source: (b)(6).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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the ins was on high¿frequency, pain relieve was okay.When the patient lays on her back and lifts her head, suddenly she feels electric sensations.¿all impedances were okay.It was noted that in the past adaptivestim was tried but with no success.¿in the last session the device was changed from 1200hz/200ysec to 1200hz/90ysec, hoping it would help.The mdt data did not show any irregularities.
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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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Event Description
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Additional information received stated that working with the adaptivestim and reducing the ysec had ¿no positive change.¿ the issue remained unresolved at the time of follow-up.It was noted that the ins remained implanted and in use at the time of report.Since the patient reported sufficient pain relief, the ins was not to be explanted.There were no further complications reported or anticipated.
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Search Alerts/Recalls
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