MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37601 |
Device Problems
High impedance (1291); Application Program Problem (2880); Loss of Data (2903); Operating System Becomes Nonfunctional (2996)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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It was reported that the patient had experienced two times when checking after an ins replacement that they got an invalid data error message showing when connecting to the tablet.They had no choice but to click ok to continue and then that would reset all of their settings and stimulation.The cause of the issue was unknown, but there were no symptoms reported.Additional information was received: it was reported that the complete setup was cleared, so they had to reset all the information from 0 (patient, diagnosis, components, others and activate).The hcp was not able to re-program the settings after confirming the error.The patient wasn't receiving good therapy yet either because the impedances were too high for all contacts and the hcp was planning a surgical check up of the system to account for the high impedances of the right lead.Additional information was received: it was reported that the physician encountered the "stuck in set-up" that happened with an older app version, but could still happen with the current one being used.
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Manufacturer Narrative
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Concomitant products: product id: a610, serial#: unknown, product type: software.Product id: neu_unknown_lead, lot#:unknown, product type: lead.Other relevant device(s) are: product id: a610, serial/lot #: unknown; product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Continuation of d10: product id: a610; serial #unknown; product type: software; product id: neu_unknown_ext; lot #unknown; product type: extension.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 was received: it was reported that the surgery was done (b)(6) 2022.The extension cable was replaced and the old one was discarded.
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Search Alerts/Recalls
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