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Model Number C315S1002 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Cardiac Tamponade (2226); Cardiac Perforation (2513)
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Event Date 12/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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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 during the of the implantable pacing lead (ipl) on the right side, insertion of the lead became difficult because due to the delivery catheter was kinked, and a site with favorable threshold could not be found in the area that was reached with the delivery catheter.It was also reported that the patient's blood pressure gradually decreased during manipulation of the delivery catheter.Therefore, the ipl was removed and replaced with a right atrial (ra) lead.The ra lead was successfully placed at a site where favorable data was measured.However, the patient's blood pressure decreased, and an echocardiography was placed over the chest and confirmed cardiac tamponade due to perforation.A drainage procedure was performed, the patient's blood pressure recovered and the procedure was continued.The ra lead was implanted, and the procedure was successfully completed.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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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 delivery catheter was returned and analyzed.The analysis indicated that the mechanical operation of the catheter shaft was kinked/buckled.The mechanical operation of the catheter was analyzed.The mechanical operation of the catheter was damaged.Visual analysis of the delivery catheter indicated damage during use.The analyst noted the delivery catheter was returned without the dilator.There is blood in the hemostasis valve.The shaft is twisted at 18.5 centimeters.The shaft is kinked at 41.7 centimeters.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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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 during the of the implantable pacing lead (ipl) on the right side, insertion of the lead became difficult because due to the delivery catheter was kinked, and a site with favorable threshold could not be found in the area that was reached with the delivery catheter.It was also reported that the patient's blood pressure gradually decreased during manipulation of the delivery catheter.Therefore, the ipl was removed and replaced with a right atrial (ra) lead.The ra lead was successfully placed at a site where favorable data was measured.However, the patient's blood pressure decreased, and an echocardiography was placed over the chest and confirmed cardiac tamponade due to perforation.A drainage procedure was performed, the patient's blood pressure recovered and the procedure was continued.The ra lead was implanted, and the procedure was successfully completed.No further patient complications have been reported as a result of this event.
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Event Description
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It was reported that during the implantable pacing lead (ipl) implant on the right side, insertion of the lead became difficult because due to the delivery catheter was kinked, and a site with favorable threshold could not be found in the area that was reached with the delivery catheter.It was also reported that the patient's blood pressure gradually decreased during manipulation of the delivery catheter.Therefore, the ipl was removed and replaced with a right atrial (ra) lead.The ra lead was successfully placed at a site where favorable data was measured.However, the patient's blood pressure decreased, and an echocardiography was placed over the chest and confirmed cardiac tamponade due to perforation.A drainage procedure was performed, the patient's blood pressure recovered and the procedure was continued.The ra lead was implanted, and the procedure was successfully completed.No further 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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Search Alerts/Recalls
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