MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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Model Number 37612 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problems
Dysphasia (2195); Shaking/Tremors (2515); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)
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Event Date 07/21/2023 |
Event Type
malfunction
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Event Description
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It was reported that the patient programmer won't connect to the implantable neurostimulator (ins).The caller stated that they changed the batteries recently and the confirmed they are not heavy duty or rechargeable batteries and stated that the screen will not turn on.The caller stated that the patient charged their ins last night and as of today were jerking and shaking.The caller also stated that the patient can't feed themselves and the patients voice is effected.Agent had the caller start a charging session and recharger showed the ins was turned off and showed the charge complete screen.The caller stated that their therapy always stays on and they are unsure why therapy is currently turned off.The caller reported to seeing the physician recently due to needing a eeg for the patient's seizers.Agent redirected to the healthcare provider to provide assistance to the patient in resuming therapy.A replacement programmer was sent.
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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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Manufacturer Narrative
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Section d information references the main component of the system.Other relevant device(s) are: product id 37642 lot# serial# (b)(6): product type programmer, patient 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 received from the healthcare provider (hcp) reported the cause of the implant being off and the programmer not connecting was due to the programmer not working.A new programmer was sent to the patient which resolved the issue.
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Search Alerts/Recalls
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