MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTMA1QQ |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Shock from Patient Lead(s) (3162)
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Event Date 02/15/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: 6935m62, lead; implanted: (b)(6) 2017.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 reported that the patient had open heart surgery followed by another open heart surgery approximately two weeks later.There were many stored episodes of noise and oversensing noted during the procedures, possibly due to cautery.During the most recent open heart surgery, inappropriate high voltage therapy was delivered due to oversensing and a lead integrity alert (lia) was also noted to be triggered due to the cautery which induced noise and oversensing on the right ventricular (rv) lead.The cardiac resynchronization therapy defibrillator (crt-d) and lead remain in use.No patient complications have been reported as a result of this event.
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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 indicated unexpected delivery of ventricular tachyarrhythmia therapy.Analysis of the device memory indicated noise.Analysis of the device memory indicated oversensing.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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