Model Number 3387S-40 |
Device Problem
Low impedance (2285)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/18/2019 |
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 health care professional (hcp) by a manufacture representative (rep) regarding an implantable neurostimulator (ins) for the treatment of dystonia.During stage, i procedure the surgeon placed the lead for the right side.An impedance test was run that showed a low impedance on contact combination 0/1.The surgeon loosened the lead stop holding the lead in place and ran another impedance test that showed the same low.The surgeon resecured the twist-lock cable adapter and the impedance test showed the same low.It was reported the surgical manipulation could have caused the issue.The lead stop may have been over tightened.The surgeon did not feel that it was tightened too much.Several impedance tests were run.The rep grabbed a different lead, and the surgeon used the new lead and there were no impedance issues.During the stage ii procedure, the surgeon tunneled and placed the extensions.The extensions were connected to the leads and plugged into the battery.An impedance test was run and found a high on all combinations of contact 9.The surgeon reconnected the extension into the battery and the lead into the extension.It did not appear that there was excessive force used when p lacing or connecting the extension.The same high came back again.A twist-lock cable was used to test the lead, there was not an impedance issue on the lead.A new extension was placed and connected to the battery and lead.The final impedance test showed normal impedance values.No symptoms or complications were reported or anticipated.
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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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Manufacturer Narrative
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Analysis of the lead (3387s-40) revealed the #0 and #1 conductors cross over under the #0 connector sleeve causing a short between the conductors.Analysis of the extension ((b)(4)) revealed no anomaly.If information is provided in the future, a supplemental report will be issued.
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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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Search Alerts/Recalls
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