Model Number 5392 |
Device Problems
Connection Problem (2900); Operating System Becomes Nonfunctional (2996)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 04/01/2024 |
Event Type
Injury
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Event Description
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It was reported that during use of the external pulse generator (epg) and patient cable with the pacing electrode there was a failure of the epg when the patient was moved from chair to bed.The patient went into cardiac arrest and cardiopulmonary resuscitation (cpr) was performed.It was noted that there was a poor connection with the epg and patient cable.The epg function recovered for a long enough period for it to be replaced.The user provided feedback that the epg model required additional connecting cables between the epg and the electrode when compared with the older model which caused connection issues.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Continuation of d10: product id mdt-cable.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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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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Event Description
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It was further reported that a subsequent inspection by the technical department of the facility found the lead in the patient cable to be broken on the ventricular side.It was noted that the patient cable was a competitor company product.It was clarified by the customer that the reported issue was related to the patient cable not the epg.
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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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Search Alerts/Recalls
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