MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37612 |
Device Problems
Overheating of Device (1437); Noise, Audible (3273)
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Patient Problems
Burning Sensation (2146); Insufficient Information (4580)
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Event Date 08/20/2021 |
Event Type
malfunction
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Event Description
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It was reported that the patient had not been the same as they had been prior to getting the rechargeable implantable neurostimulator (ins) implanted.Patient felt they had lost ground and, as they have parkinson's, they had not expected to gain ground, but they noticed they were definitely not the same since they had the ins replaced.The patient also stated that this morning, around 1 am, they could hear a distinct sound coming from their ins, like a background hum/buzz, followed by their left side of their chest they could feel a heat sensation.Patient described it like a scalpel was dissecting their left side that felt hot.The patient did not feel pain or a stabbing sensation, just a heating sensation that lasted about 1 minute.Patient stated they had not felt anything like that before and since the feeling subsided.The patient was redirected to their healthcare provider (hcp) to further address the issue.Patient's next appointment with hcp was approximately (b)(6).
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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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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 consumer reported they used the remote charger the day before the issue occurred (they typically charged two hours every other day).The consumer went to bed around 9 p.M.And fell asleep.About three hours later the consumer was going to start the charging process, but before they placed the recharger on the implant site, there was a spontaneous resolution, and the issue was resolved.The consumer mentioned their family members didn¿t think the rechargeable device was as effective as the non-rechargeable device they previously had.
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