Model Number 37612 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 the patient turned their deep brain stimulation (dbs) system off for the duration of their pregnancy and the device was likely overdischarged.The provider tried to interrogate the generator for troubleshooting.No actions/interventions have yet been taken, however the manufacturing representative (rep) stated they would attend the patient's appointment with their neurology provider on 2020-01-30 to provide guidance and assist in reviving the implantable neurostimulator (ins) from "probable overdischarge state." on 2020-01-24 (b)(4) (rep): no new information.
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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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Additional information was received from the rep reporting that the issue was not confirmed to be caused by the overdischarge.The patient was seen and it was indeed in a state of overdischarge.Under the direction of the healthcare provider, they reset the patient's generator using her charging unit.It was determined by the healthcare provider and patient that the overdischarge was caused by the patient turning off the generator for the duration of their recent pregnancy.
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Manufacturer Narrative
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D2/g5: please note that this device was used in an off-label manner as it was implanted for dystonia.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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Search Alerts/Recalls
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