MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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Model Number 37612 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
Shaking/Tremors (2515)
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Event Date 09/09/2023 |
Event Type
malfunction
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Event Description
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It was reported that within the past 2-3 days, the patient noticed they were shaking.The patient said the shaking was horrible, noting that their hands were shaking the worst.The patient added that they could not put their earrings or makeup on.The agent did not ask about the circumstances that led to the reported issue.The patient called to learn how to use the handset, the communicator, and the dbs therapy app.The agent reviewed the requested information, and the patient could see that therapy was turned off.The patient did not know why therapy was turned off.The patient turned therapy on and said they could feel electricity going through them.The patient confirmed that the therapy was helping with the shakes.The patient's ins was 100% charged, and it was reviewed on how to use it. the patient thought they were supposed to use the handset and communicator to charge their implant.The agent checked the difference between the recharger and handset/communicator and what each set of equipment was used for.The agent advised the pati ent to keep their implant charged to prevent therapy from turning off.The patient confirmed that they understood.The patient did not require further assistance.
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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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