Model Number DTBA1D4 |
Device Problems
Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
|
Patient Problem
Shock from Patient Lead(s) (3162)
|
Event Date 04/03/2024 |
Event Type
Injury
|
Event Description
|
It was reported that the patient received potentially inappropriate anti-tachycardia pacing and a shock from the cardiac resynchronization therapy defibrillator (crt-d) for an supra ventricular tachycardia (svt) episode which was detected as ventricular fibrillation (vf).It was also reported that right atrial (ra) lead undersensing was noted on the stored electrograms (egm).The crt-d and ra lead remain in use. no further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Continuation of d10: 419388 lead implanted (b)(6) 2008.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
It was further reported that the patient is deceased.The cause of death was requested but could not be obtained.
|
|
Manufacturer Narrative
|
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Search Alerts/Recalls
|