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 Problem
Shaking/Tremors (2515)
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Event Date 02/27/2024 |
Event Type
malfunction
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Event Description
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Information was received from a patient's representative regarding an implantable neurostimulator (ins).The caller reported that the patient started shaking this morning.At the time of the call, the patient was charging the ins and the recharger app indicated that therapy was off and the ins was 50% charged.The caller did not know why therapy was turned off.Agent reviewed that therapy may have turned off due to the ins charge level getting too low.During the call, agent reviewed how to turn therapy back on using the dbs therapy app and tm90 communicator.However, the communicator would not power on because it was out of charge.The caller said they will charge the communicator, then will use it in conjunction with the dbs therapy app to turn therapy back on.The caller was advised to call back if they require further assistance.
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Manufacturer Narrative
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Continuation of d10: product id tm90d0 (serial: (b)(6)); product type: 0001-accessory; implant date n/a; explant date n/a 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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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information received from the consumer reported the circumstances that led to the implant being off was them being sick for a period of time and not fully charging the device.The consumer spoke with someone who was good with electronics to resolve the issue.
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Search Alerts/Recalls
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