Model Number EV240152 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Decreased Sensitivity (2534)
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Patient Problem
Shock from Patient Lead(s) (3162)
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Event Date 03/06/2024 |
Event Type
Injury
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Event Description
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It was reported that the extravascular (ev) lead exhibited small r-waves and several oversensing/noise episodes that resulted in many inappropriate shocks.The ev lead remains in use. no further patient complications have been reported as a result of this event.
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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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It was further reported that a procedure was performed in which the physician obtained sensing amplitude measurements while pulling the lead out to determine if the amplitude would be better in a different position.The ev-lead was ultimately explanted.Six days later, the patient received a transvenous system.
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Manufacturer Narrative
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Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing.Analysis of the device memory indicated diminished right ventricular sensing.Analysis of the device memory indicated unexpected delivery of ventricular tachyarrhythmia therapy.Analysis of the device memory observed noise on the electrogram waveforms.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Product event summary: the full lead was returned and analyzed.No anomalies were found.There was body tissue/fibrotic growth on the d1 exposed defibrillation coil of the lead.The analyst noted there all electrical testing was within specified parameters.No insulation breach or conductor fracture was observed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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