MEDTRONIC EUROPE SARL COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
|
Back to Search Results |
|
Model Number DTPA2QQ |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Unspecified Infection (1930); Gastrointestinal Hemorrhage (4476)
|
Event Date 12/01/2023 |
Event Type
Death
|
Event Description
|
It was reported that while hospitalized for a gastrointestinal bleed and unspecified infection, the right ventricular (rv) lead exhibited t-wave oversensing (twos) on the presenting electrogram.No corrective action was taken for the twos.It was reported by the patient's daughter that the patient could expire at any time.A magnet was placed over the patient's cardiac resynchronization therapy defibrillator (crt-d) by hospice care.The patient expired at home the following day.No additional information was available regarding the infection though the infection and death were reportedly unrelated to the crt-d system that was implanted approximately nine weeks prior.The patient was a participant in a clinical study.No additional information was reported.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Correction: imf (annex f) health impact code.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
|
|
|