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Model Number SEDR01 |
Device Problems
Premature Discharge of Battery (1057); Capturing Problem (2891); Communication or Transmission Problem (2896)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 03/12/2024 |
Event Type
Death
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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 reported that the patient exhibited cardiac arrest and the cardiac resuscitation was performed by paramedics.Physician tried to interrogate the implantable pulse generator (ipg) but there was no telemetry and it was impossible to interrogate.External ipg was placed, the patient was stabilized but after one hour the exit block of the external lead was observed.It was also noted that the increased thresholds caused the faster battery depletion.The patient subsequently died.Additional information regarding the cause of death was requested and not received.
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Manufacturer Narrative
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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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was further reported that the physician did not believe the patient's death was linked to the performance of the ipg as the external ipg was also unable to stimulate effectively.
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Search Alerts/Recalls
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