MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number B35200 |
Device Problem
Loss of Data (2903)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 hcp interrogated patient's implant today and all the programming was wiped out.Manufacturer representative (rep) said she was at the replacement surgery on (b)(6) 2021, and supposedly patient hasn't seen anyone until today.The only other possibility was when patient experienced facial drooping on (b)(6) and patient had ct scan with contrast.Technical services (ts) reviewed with rep that most likely scenario is perhaps patient saw someone that used 8840 or a lower software tablet version to connect to patient's implant, thus it wiped out the programming.Rep doesn't believe hcp wiped out programming since their tablet is up-to-date.Rep will be at patient next appointment in (b)(6).And she will try and get the json files to see if any data can be gathered that may help get an understanding of what might have happened to wipe the data out.The data may have been wiped out since hcp interrogated patient's implant today.The caller was not with the patient. the issue was not resolved.
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Event Description
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Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the cause of the programming being wiped out wasn¿t determined.The hcp programmed new settings which resolved the issue.
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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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