MEDTRONIC NEUROMODULATION NEUROMODULATION DEVICE; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number NEU_UNKNOWN |
Device Problem
Labelling, Instructions for Use or Training Problem (1318)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/10/2023 |
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) for urinary/bowel dysfunction and urge incontinence.It was reported that they had been reading through all the literature again with their spouse and, when they were looking at the medtronic interstim x system therapy guide there is a barcode for patients to scan that is supposed to take them to a site on their personal phone where they could view instructional videos about the therapy.The patient stated they scanned the barcode with their phone, and it took them to an entertainment website with movies and dances, etc.The patient stated they didn't realize at first it was the wrong site and they were clicking the links that came up once they followed the barcode to the site and they think they signed up for a subscription for something.The patient stated it was "like youtube or something" and it was nothing to do with medtronic.The patient stated they were going to have to check their bank account to make sure nothing came out.Patient services sent the patient an email with links for the instructional videos they were looking for and told the patient the case would be documented.Documented reported event.No further action was taken by patient services.
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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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