MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC FREEDOM DRIVER; ARTIFICIAL HEART

Model Number 400089-001

Device Problems Air Leak (1008); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2017

Event Type  malfunction  

Event Description

The patient was implanted with syncardia tah, but while traveling in (b)(6) presented at another hospital with fracture of the right cannula.There was a pneumatic driveline/air leak.The patient was transferred to companion 2 driver while the repair was made, then returned to freedom driver.Section returned to syncardia.A second repair done at reporting facility.

• Brand Name: FREEDOM DRIVER
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 6636508
• MDR Text Key: 77423957
• Report Number: 6636508
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: 400089-001
• Device Lot Number: 104168 (RV)
• Other Device ID Number: MODEL NUMBER 500101
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2017
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES