Model Number 37612 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 09/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of the event: (b)(6) 2018.Is an estimate if information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a manufacture representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for dystonia and movement disorders.It was reported that the patient cannot communicate with the recharger, the clinician programmer, clinician tablet or the patient programmer (pp).It is unknown when the patient last charged but it was quite a while, and the patient did not feel like they were getting therapy.Patient last successfully charged in (b)(6) 2018.The patient's recharger was not available to pull the recharger statistics.It was reviewed for the rep to attempt antenna locate (al) feature (if available) to determine optimal antenna position, and document resulting values 60-112.Trouble shooting steps were reviewed for the rep.The rep alter caller back and noted that the patient had emerged from over discharge and was charging with 8 coupling boxes.The rep saw power on reset (por) and the recharger by passed it.It was reviewed for the rep to interrogate with tablet and pp when the ins is at 25% to ensure por is cleared.No further patient complications were reported/ anticipated as a result of this event.
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Manufacturer Narrative
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The correct aware date is 2019-02-13 and 2019-02-14 as initially submitted.If information is provided in the future, a supplemental report will be issued.
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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 patient stating that therapy was restored after the device was brought out of over discharge.
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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.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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