MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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Model Number 37612 |
Device Problems
Failure to Deliver Energy (1211); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Visual Impairment (2138); Shaking/Tremors (2515); Sleep Dysfunction (2517); Electric Shock (2554)
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Event Date 12/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: 37751, serial#: unknown, product type: recharger.Product id: 37642, serial#: unknown, product type: programmer, patient.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 consumer who reported ¿two mornings ago¿ they woke up and of a sudden their tremors returned as they started to get out of bed so they hadn¿t slept very well.The consumer mentioned they forgot to charge their implant and confirmed they charged their implant before calling.The consumer was unable to turn therapy back on, but they hadn¿t tried using the programmer to turn therapy on.During the call the consumer powered on the programmer and saw the warning screen that indicated the programmer batteries needed to be replaced.The batteries were replaced, and the programmer synced with the implant which showed therapy was off and the battery level was okay.The consumer was then able to turn therapy back on and it was the ¿bigger jolt¿ they ever had, and their vision was impaired temporarily.Following this the consumer¿s tremors were feeling a ¿whole lot better.¿ unrelated ¿rush¿ when turning therapy on event captured in (b)(4).
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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 consumer reporting the cause of the battery being off was due to forgetting to charge in a timely way.
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Search Alerts/Recalls
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