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Model Number 37022 |
Device Problems
Break (1069); Electromagnetic Interference (1194); Low impedance (2285)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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Other relevant device(s) are: product id: b3300542m, serial/lot #: (b)(4), ubd: 06-sep-2024, udi#: (b)(4).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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It was reported that there were low impedance values/potential short for bipoloar impedances on left hemisphere lead during stage 2 implant.No environmental/external/patient factors that may have led or contributed to the issue were identified.Surgical intervention is planned to replace the left hemisphere lead.During the stage 2 implant procedure, the proximal part of the left hemisphere lead was caught in the patient's tissue.The physician used cautery to free the lead from the tissue.When impedances were tested for that lead, the bipolar impedances showed shorts between contact 2a and 1a, and also between 1a and 0.Therefore the lead was tested via a lead test cable and showed similar impedances issues (shorts for bipolar impedances for the combination of 2a and all other contacts).The end of the lead was wiped with a sterile 4x4, and the lead was adjusted in the lead test cable, and the lead was also reconnected to the extension and tested impedances at the battery site.Similar results were observed with the impedances with every test.Finally, the physician surmised that he may have broken the insulation of the lead in that area where he had cauterized to free it from the tissue.He plans to reimplant a new lead in a revision case.
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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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Event Description
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Additional information was received.The left lead was replaced in a revision surgery and the impedance issue was resolved.
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Search Alerts/Recalls
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