Model Number 37612 |
Device Problem
High impedance (1291)
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Patient Problems
Pain (1994); Neck Pain (2433)
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Event Date 06/07/2019 |
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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Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for dystonia and dbs therapy indications.It was reported "3, 2, 1" contacts showing greater than 40000 ohms.The day of implant the impedances were 900-1500 ohms.X-ray did not show any fractures.It was also reported the patient had surgical pain at the surgery site.This was noted as gradual and from the tunneling in the head/neck area.They had an er visit.No further complications were reported as a result of this event.
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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 hcp via the rep stating the surgical pain was from the tunneling of the procedure and the impedances had not been resolved and they were hoping to continue to get therapeutic benefit on contact 0 according to the hcp.It was reported additional positional impedance checks would be done when the patient was seen in the clinic.The issue was not resolved at the time of the report.
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Manufacturer Narrative
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D2: 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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