MAUDE Adverse Event Report: SYNCARDIA SYNCARDIA TAH-T DRIVELINE; TOTAL ARTIFICIAL HEART DRIVELINE

Model Number 400008-001

Device Problems Radiation Leak (1357); Pressure Problem (3012)

Patient Problems Death (1802); Shock (2072); Shock (2072)

Event Date 11/29/2019

Event Type  Death  

Event Description

Total artificial heart implanted on (b)(6) 2016.On (b)(6) 2016, a hissing sound and an alarm were generated by the system portable driver.Interventions performed.Pt continued to decompensate and expired on (b)(6) 2019.

• Brand Name: SYNCARDIA TAH-T DRIVELINE
• Type of Device: TOTAL ARTIFICIAL HEART DRIVELINE
• Manufacturer (Section D): SYNCARDIA ; 1992 e. silverlake rd; tucson AZ 85713
• MDR Report Key: 9511571
• MDR Text Key: 241260777
• Report Number: 9511571
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 400008-001
• Device Lot Number: 104690
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2019
• Distributor Facility Aware Date: 11/29/2019
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Death
• Patient Age: 22 YR