MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97714 |
Device Problems
Unintended Collision (1429); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
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Patient Problems
Burning Sensation (2146); Electric Shock (2554)
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Event Date 08/01/2021 |
Event Type
malfunction
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that they have had some bad falls right on the implant site, but could not recall when they happened, but that they might be related to the issues they are having.Pt noted that a couple of months ago, they have felt electrical sensations that have gotten worse at times.Pt said one time they were walking in (b)(6), and they were aware that they had not turned on their stimulator, and out of no where, they felt like an electrical burning from the bottom of their bra area to the bottom of their feet, almost like something outside of them hit, and they felt more and more electrical sensations in their legs.Pt said it feels like they have their stimulator set way up high but they don't.Pt also noted that their setting for when they lay on their side only works on to lay on one side but not the other.Pt said the issue is becoming aggravating.Pt said they lost the name for their medtronic rep.The patient was redirected to their healthcare provider to further address the issue.
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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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Additional information received.Patient reported they dropped stimulation strength and was reprogrammed.Patient reported issue not resolved.Patient reported now having constant modes vibrations from middle back hips.Strength increases when night falls and stings.
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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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