MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37601 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885); Insufficient Information (3190)
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Patient Problems
Dysphagia/ Odynophagia (1815); Fatigue (1849); Coma (2417); Loss of consciousness (2418); Cognitive Changes (2551)
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Event Date 07/12/2022 |
Event Type
Injury
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Event Description
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It was reported that a few days ago the patient was brought to the hospital for a hip replacement.The patient representative (patient rep) said right prior to the hip replacement surgery, the patient was really groggy. surgery was 2 days ago but the patient still hasn't woken up.The patient rep said the dbs hcp said that the patient didn't need to turn dbs off for hip replacement surgery.The caller said after the surgery was done, the patient hadn't woken up and had a lack of responsiveness as they were in a near vegetative state. the patient had been given several medical tests to see why this was, but nothing wrong could be found with the patient.The patient rep decided to check the ins (implantable neurostimulator) and found that it was at eos (end of service).The patient rep said the ins being at eos must have been why the patient wasn't waking up.The patient rep was surprised that ins was at eos because the patient had seen the dbs hcp in (b)(6) 2022 and told the patient that their ins had months-years left.The patient rep said because of this, they knew something was wrong with the ins because the battery had depleted so quickly.The patient now has covid and the patient rep said due to this, the patient wouldn't be able to get a battery replacement surgery for at least 6 or 7 days.The patient was redirected to their healthcare provider to further address the issue.The patient rep said the patient's medications had to be changed because the patient was on a feeding tube so they couldn't swallow medication so they were given carbidopa and levodopa in a different way now.
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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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Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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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H3: product analysis #282337068:analysis information -- (b)(4) 11:03:22 cst pli# 10 product id# 37601 the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.Analysis observed no output or telemetry on the implantable neurostimulator (ins) and determined normal battery depletion.No significant anomaly was observed.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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