Concomitant medical products: dtma1d1 crt-d, implanted: (b)(6) 2019, explanted: (b)(6) 2019; product id: 694765 lead, implanted: (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.
|
It was reported that the patient presented to the emergency room with a syncopal event, incontinence, edema and redness bilaterally on lower extremities with suspected cellulitis.The left pectoral cardiac resynchronization therapy defibrillator (crt-d) site was red and hot to the touch and the patient was febrile.Suspected pocket infection was noted.Pocket evacuation and a drain was inserted.Cultures were sent and the patient received antibiotic treatment.The crt-d system was later explanted and replaced.No further patient complications have been reported as a result of this event.
|