MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37601 |
Device Problems
Unintended Collision (1429); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Fall (1848); Shaking/Tremors (2515); Ambulation Difficulties (2544)
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Event Type
malfunction
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Event Description
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It was reported that patient has had tremors since 2012, and needs to go in for routine tweaking of therapy. patient asking for physician listings for help in managing dbs.Patient services (pss) emailed physician listings per caller request. patient representative mentioned patient has fallen 5 times in the last week, and yesterday, when the patient rep was helping the patient stand up, they noticed the patient's legs were not stable.Caller stated they were afraid that due to the falls, the wires in the patient may have been affected.
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Manufacturer Narrative
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Concomitant medical products: product id 3389s-40, serial# unknown, product type: lead.Other relevant device(s) are: product id: 3389s-40, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
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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 the patient.The cause of the patient's legs not being stable and falling could not be determined as they cannot find a healthcare provider locally that works with dbs patients so no actions or interventions could be taken to resolve the issue.
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Search Alerts/Recalls
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