Citation: tarzia v, et al.Totally peripheral approach for icd lead vegetation removal in a guch patient.J cardiovasc electrophysiol.2021 jun;32(6):1778-1781.Doi: 10.1111/jce.15032.Epub 2021 may 12.Earliest date of publish used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.
|
Medtronic received information from a literature case report regarding a male patient who was diagnosed at birth with pulmonary atresia and subaortic ventricular septal defect and underwent several surgical procedures in the ensuing years to correct and treat the congenital heart disease.At an unspecified age, the patient was implanted with a medtronic melody transcatheter pulmonary valve (unique device identifier number not provided).At an unknown time after melody implant, at the age of (b)(6) years, the patient had a dual chamber-implantable cardioverter defibrillator implanted for third-degree atrioventricular block and previous ventricular malignant arrhythmias.No additional adverse patient effects or product performance issues associated with the melody valve were reported.
|