Model Number 479888 |
Device Problems
Activation, Positioning or Separation Problem (2906); Device Contamination with Chemical or Other Material (2944); Positioning Problem (3009)
|
Patient Problem
Thrombosis/Thrombus (4440)
|
Event Date 11/22/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that during implant of the left ventricular (lv) lead placement was difficult.It was noted that the lv lead wire lumen was stuck due to thrombus.It was also reported that the guidewire could not be passed through the lumen of the lv lead.The lv lead was removed and replaced with a different lead.When the lv lead was checked after it was taken out of the patient's body, an object believed to be either myocardial tissue or lead material was confirmed on the lead tip, apart from the thrombus.No further patient complications have been reported as a result of this event.
|
|
Event Description
|
It was further reported that the thrombus occurred during the implant procedure.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Product event summary: the full lead was returned and analyzed.No anomalies were found.There was blood on the distal conductor of the lead, and it was not obstructed.The tip seal on the distal electrode of the lead showed evidence of blood ingression.The analyst noted the guidewire was not returned, using a sample of medtronic attain guidewire model gwr419488 to perform insertion test, it passed throughout the df-4, the coil lumen, and the lead distal tip.There was dried blood in lead tip nose and on the conductors, but it was not obstructed.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.
|
|
Search Alerts/Recalls
|
|