MEDTRONIC SINGAPORE OPERATIONS ENSURA SR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number EN1SR01 |
Device Problem
Pacing Problem (1439)
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Patient Problems
Cardiac Arrest (1762); Tachycardia (2095)
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Event Date 03/31/2024 |
Event Type
malfunction
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Event Description
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It was reported that the patient experienced a cardiac arrest and ventricular tachycardia (vt).It was also reported that the ipg potentially went into magnet mode and paced inappropriately during the cardiac arrest and the right ventricular (rv) lead exhibited undersensing of arrhythmia due to quiet timer blanking (qtb). the patient was hospitalised.The ipg system was reprogrammed and 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 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 device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory had an observation relating to pacing.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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