MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 37714 |
Device Problems
Unstable (1667); Charging Problem (2892); Patient Device Interaction Problem (4001)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/15/2021 |
Event Type
Injury
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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 who was implanted with an implantable neurostimulator (ins) for non-malignant pain and radic ulopathy.The patient felt like what may have happened maybe about a week ago was that the ins flipped over.Pt stated that they went to recharge the ins today, however the reposition antenna screen kept appearing on the insr.Pt stated that normally they could feel little buttons on the ins through their skin so they would know where to place the insr antenna paddle over the ins, however they were feeling something like a bar across the ins instead of the little buttons.Pt stated that as they were getting up the other day, the ins kind of went and flipped halfway.Pt stated that they pushed the ins back, however they weren't sure if the ins went back in the right spot or not.Pt stated that they never liked the way that hcp installed the ins.Pt stated that they were at the point where they didn't want to use the device anymore.Pt stated that they normally didn't have problem with the ins, although sometimes they would have to fight with the equipment to recharge the ins, however they were still able to recharge the ins.Pt stated that they didn't care anymore and that they wanted the device removed. the patient was redirected to their healthcare provider to further address the issue.
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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 the patient reporting that they felt a ¿ping¿ sensation with their old implant, which ended up having to be replaced.
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Search Alerts/Recalls
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