MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problems
Dysphagia/ Odynophagia (1815); Muscular Rigidity (1968); Urinary Tract Infection (2120); Shaking/Tremors (2515)
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Event Date 01/24/2024 |
Event Type
Injury
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Event Description
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Information was received from a patient's representative (rep) regarding an implantable neurostimulator (ins).The rep reported that last wednesday the patient's tremor in their right arm got worse and their body was very stiff.The rep added that the patient had trouble swallowing, noting that they were not swallowing their medication or food.Additionally, the patient had a really bad urinary tract infection.The rep stated that the patient was hospitalized on sunday and had an ng tube inserted to give the patient their medication and nutrients.The rep was charging the patient's ins and was monitoring the charge session with the recharger app, which was when they noticed therapy was off.The rep tried to turn therapy back on using the communicator and dbs therapy app, but they got the error message 'communicator not found.' rep was directed to patient services and they were able to successfully pair the communicator with the handset.The rep confirmed they were able to turn therapy on and stated that the patient's tremor stopped.The patient's ins was 75% charged at the time of the call.The rep was redirected to the patient's healthcare provider to further address the other symptoms the patient was experiencing.
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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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