MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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Model Number 37603 |
Device Problem
Battery Problem (2885)
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Patient Problems
Fall (1848); Shaking/Tremors (2515)
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Event Type
Injury
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Event Description
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It was reported that the patient had been shaking pretty bad and requested assistance with charging the patient's implantable neurostimulator (ins) as they believed the patient had not charged their ins in a long time.The caller stated they were not sure how long the patient had been shaking, and added that the patient was previously in a rehab facility due to a fall on july 9th, and they were not sure if the fall was related to the dbs device, but that they imagine it was as several people had informed the caller that the shaking had been going on for a while.The caller did have the patient programmer, but was not able to find the recharging equipment and the patient did not know where the equipment was.Agent reviewed with caller that they would not have a recharger as the implant is primary cell battery.Caller repeated information regarding the patient symptoms stating they are shaking really bad.Agent walked caller through checking implant status with the programmer and caller confirmed seeing eri.Agent reviewed how to bypass this message and caller confirmed stimulation was on.Agent reviewed eri meaning and redirected to hcp.
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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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