This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.If information is provided in the future, a supplemental report will be issued.
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It was reported that about four days after the cardiac resynchronization therapy defibrillator (crt-d) implant procedure, the patient experienced a deep vein thrombosis in the left upper extremity, as well as difficulty breathing, fatigue, and reduced appetite.The blood clot was treated with medication and the device remains in use.The patient was a participant in the adapt response study.No further patient complications have been reported as a result of this event.
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