MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97714 |
Device Problems
Intermittent Continuity (1121); Failure to Deliver Energy (1211); Unintended Collision (1429); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 07/22/2020 |
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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The patient reported that they had a terrible accident where a tractor flipped over them and they were in the hospital.They stated that they attempted to charge the implantable neurostimulator (ins) on the day of the report and the ins was still charged.The patient mentioned that they typically run their stimulation non-stop.They added that they turned their stimulation on, and after a minute or so, their stimulation turned back off.They did this again at the time of the report, and the stimulation turned off again.The patient connected to their programmer, and they turned their intensity up high, and then was able to feel stimulation after moving a certain way.The patient was redirected to follow-up with their healthcare provider to have their device checked.
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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 was received from a consumer regarding the patient.It was reported that the stimulation turning off on its own has been resolved.The patient noted that there was never anything wrong with the stimulator.The patient noted that the stimulator has been working all the time.The patient noted that the problem was that they had gotten in their accident and broken 15 ribs and spent a week in the trauma unit.
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Search Alerts/Recalls
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