MEDTRONIC EUROPE SARL AMPLIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTMB1QQ |
Device Problems
Misconnection (1399); Unable to Obtain Readings (1516)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2023 |
Event Type
malfunction
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Event Description
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It was reported that an alert triggered for right ventricular (rv) lead defibrillation impedance of 180 ohms with an alert threshold of 130 ohms. additionally, the remote transmission data showed clear non-physiologic noise on both rvtip to rvcoil and rvcoil to can, that showed clear evidence of a rvcoil fracture or connection issue. it was noted that given the rv lead is relatively a newly implanted lead, that the issues are most likely due to a connection issue with the cardiac resynchronization therapy defibrillator (crt-d). the patient stated that this happened on the same day that the patient was moving the lawn with a push mower. rv lead noise was present on tip to coil and can to coil electrogram (egm) with arm movements but no noise present on the bipolar egm. manual testing of rv lead impedance showed variance of rv coil impedance and tip to coil high impedance. the rv lead detection was turned off and, the lead was explanted and replaced two days later. it was also reported that the crt-d remote transmission data showed invalid data for rate histograms and atrial tachycardia/ atrial fibrillation (af) grid data. the crt-d remains in use. no patient complications have been reported as a result of this event.
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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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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 that the ventricular rate histogram data was missing/invalid.Analysis of the device memory indicated an issue with missing/invalid diagnostic data.Analysis of the device memory indicated that the atrial rate histogram data was missing/invalid.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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Correction: b5 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 an alert triggered for right ventricular (rv) lead defibrillation impedance of 180 ohms with an alert threshold of 130 ohms.Additionally, the remote transmission data showed clear non-physiologic noise on both rvtip to rvcoil and rvcoil to can, that showed clear evidence of a rvcoil fracture or connection issue.It was noted that given the rv lead is relatively a newly implanted lead, that the issues are most likely due to a connection issue with the cardiac resynchronization therapy defibrillator (crt-d).The patient stated that this happened on the same day that the patient was moving the lawn with a push mower.Rv lead noise was present on tip to coil and can to coil electrogram (egm) with arm movements but no noise present on the bipolar egm.Manual testing of rv lead impedance showed variance of rv coil impedance and tip to coil high impedance.The rv lead detection was turned off and, the lead was explanted and replaced two days later.It was also reported that the crt-d interrogation report data showed invalid data for rate histograms and atrial tachycardia/ atrial fibrillation (af) grid data.The crt-d and programmer remain in use.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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