MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA TAH-T; ARTIFICIAL HEART

Model Number LV ID 104189L1215

Device Problems Air Leak (1008); Break (1069)

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

Event Date 12/01/2016

Event Type  malfunction  

Event Description

There was a break in the pneumatic driveline, resulting in air leak.The patient went to clinic, and then was admitted to fix the problem.

• Brand Name: SYNCARDIA TAH-T
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 east silverlake rd.; tucson AZ 85713
• MDR Report Key: 6236428
• MDR Text Key: 64288693
• Report Number: 6236428
• 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: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2019
• Device Model Number: LV ID 104189L1215
• Device Lot Number: 105679
• Other Device ID Number: RV ID 104170RO116
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2016
• Event Location: Home
• Date Report to Manufacturer: 12/02/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO