Model Number 439878 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erosion (1750); Unspecified Infection (1930); Discomfort (2330); Swelling/ Edema (4577)
|
Event Date 12/02/2021 |
Event Type
Injury
|
Event Description
|
It was reported that the patient's cardiac resynchronization therapy defibrillator (crt-d) pocket was infected.An incision was made to drain the pocket and the device remains in use.It was also reported that the crt-d was non-specifically not pacing or capturing properly and was pacing in the qrs complex.Undersensing with low p-waves were noted on the right atrial (ra) lead and atrial capture could not be confirmed.The lead remains in use.No further patient complications have been reported as a result of this event.It was further reported that the patient was experiencing swelling and discomfort in the pocket area.The crt-d eroded through the pocket and was hanging half out of the device pocket.The crt-d system was explanted and the patient was administered antibiotics.
|
|
Manufacturer Narrative
|
Concomitant medical product: 0125 lead, implanted: (b)(6) 1997.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.Visual analysis of the lead indicated apparent explant damage.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
|
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
|
|