MEDTRONIC EUROPE SARL CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTMA1QQ |
Device Problem
Electromagnetic Interference (1194)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that during use of the right atrial (ra) lead inappropriate atrial tachycardia/atrial fibrillation (af) episodes were recorded due to oversensing on atrial channel. it was indicated that the patient works with vehicles and impact wrenches.Noise was reproducible in clinic when recreating movements when using impact wrench and questioned if noise was associated with loose set screw or myopotentials. based on reproducibility with arm movements, myopotentials were suspected. lead noise on atrial channel is also mirrored on can to right ventricular (rv) coil electrograms (egm), but not over sensed on rv channel. additionally, it was noted that noise would not typically present on fairfield channel if atrial set screw was loose. the concurrent noisy egm signals, though not actually sensed on rv lead, are consistent with myopotentials or some sort of cardiac resynchronization therapy defibrillator (crt-d) external interference/ electromagnetic interference (emi). it was also noted, noise was only sensed on the atrial channel, and not on the nearfield rv, and there were not any additional over sensed episodes in the past two months. the ra lead and crt-d 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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Concomitant products: lda210q lead implanted: (b)(6) 2015.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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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 emi.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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