Model Number 459878 |
Device Problems
Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017); Low impedance (2285); Impedance Problem (2950)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2023 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: dtpa2qq crt-d implanted: (b)(6) 2022.Product event summary: the full lead was returned and analyzed.Analysis indicated the guidewire was broken.The distal conductor of the lead was obstructed due to a guidewire fragment stuck in the lumen.The analyst noted there was found only the distal section of unknown guidewire in lead coil lumen.It was broken in many pieces.It is possible that the guidewire distal section was broken and stuck in lead coil lumen during implant and broken off in patient.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 the left ventricular (lv) lead exhibited a spike in pacing impedance and low impedance.An insulation issue was noted with the lead.It was added that during the initial implant, an unknown guidewire was retained in the lv lead for stability.The lead was explanted and replaced.No patient complications have been reported as a result of this event.
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Event Description
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It was further clarified that the guidewire was a competitor product.
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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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Manufacturer Narrative
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Product event summary: the full lead was returned and analyzed.Analysis indicated the distal conductor of the lead was obstructed due to a guidewire fragment stuck in the lumen.The guidewire was broken.Visual analysis of the lead indicated damage at implant.The analyst noted there was found only the distal section of unknown guidewire in lead coil lumen.It was broken in many pieces.It is possible that the guidewire distal section was retained in lead coil lumen during implant, and then while of time in-vivo, that segment had been broken in three pieces.Correction: h6 (eval code conclusion- fdc/annex d), product event summary 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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