MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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Model Number 37601 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Fall (1848); Muscular Rigidity (1968); Dizziness (2194); Dysphasia (2195); Loss of consciousness (2418); Electric Shock (2554); Convulsion/Seizure (4406)
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Event Date 12/20/2022 |
Event Type
malfunction
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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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It was reported that around dec 21st, the patient was home and had just woken up and sat on the edge of the bed.The patient stated changing the programmer batteries the night before and felt a surge.It threw the patient into a frozen state, and they couldn't speak or move.The patient states getting dizzy, blacking out, and going face-first on the floor.The patient said it was like having a seizure, unable to move their body, or yelling to a friend to help.The patient states a friend stayed with her that day and started feeling better but has been having dizzy spells ever since.The patient states the programmer showed batteries were dead, so the patient was changing the batteries.The patient states the ins was not off.The patient wondered if they were pressing the wrong button that would make them surge like that.Now the programmer was in icon mode and did not show text on/ok.The patient states settings show program c,2.60, and 4.00, which the programmer usually sets at.During the call, the programmer was changed back to text mode, and the patient could see on/ok, and this issue was resolved.Pss redirected the patient to hcp to discuss therapy issues.The patient states had a dr.Appointment on jan 11 to discuss this and another appointment in february.
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Search Alerts/Recalls
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