MAUDE Adverse Event Report: THORATEC CORPORATION; VENTRICULAR (ASSIST) BYPASS

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2020

Event Type  malfunction  

Event Description

Patient was on the way to the cardiology office for his appointment with left ventricular assist device (lvad) director.In the car, he had a yellow heart alarm and the message read backup battery fault alarm.This is the 3rd alarm with the same message.They backup battery was disconnected and reconnected the first time and the second time.This time, we replaced the entire system controller, as the backup battery was new.Patient tolerated the system change well.

• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10939949
• MDR Text Key: 219331477
• Report Number: 10939949
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2020
• Event Location: Other
• Date Report to Manufacturer: 12/03/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1