MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
|
Back to Search Results |
|
Model Number 37612 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
|
Patient Problems
Fatigue (1849); Fever (1858); Headache (1880); Dysphasia (2195); Shaking/Tremors (2515); Sleep Dysfunction (2517); Cognitive Changes (2551); Electric Shock (2554)
|
Event Date 05/21/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported by the patient that about two days ago, their whole body was shaking (this included limbs, hands, and arms) for some reason.In addition to that, the patient also had insomnia (it was not specified if the patient was unable to fall or stay asleep), they had been running a fever, and their face was flush/hot/red all over.The patient's wife added that the patient was feeling tired, was not thinking straight, and was acting weird/funny.The patient's wife also mentioned that the patient had headaches and was taking pain relief medication 3-4 times a day.The patient went to the hospital for a whole day and had tests done, but they were told: that "everything was good." the patient stated that they were still shaking (including their voice, which made speaking difficult), but they did not indicate if the other symptoms had resolved.The patient stated that their reason for calling was to get some help checking their ins status to see if it would fix their symptoms.Therapy was off; the ins battery level was ok.The agent reviewed how to turn the therapy on.The patient confirmed they were able to turn the therapy on, but they experienced what felt like an electrical shock once therapy was on, so they turned therapy back off.Thus, the agent redirected the patient to their managing healthcare provider to address symptoms and for guidance on ensuring patient comfort while therapy gets turned back on.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Additional information was received from the patient who reported the new machine stopped everything, no more shaking or shocking.The issues are resolved.
|
|
Search Alerts/Recalls
|
|
|