MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 2; LEFT VENTRICULAR ASSIST DEVICE

Device Problems Device Alarm System (1012); Output Problem (3005)

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

Event Date 11/10/2021

Event Type  Injury  

Event Description

Patient at home (b)(6) 2021 when primary controller began alarming indicating emergency backup battery issues.Pt switched to backup controller with the same alarm noted.Swapped back to primary with cessation of alarms.Ebbs changed in both controllers.

• Brand Name: HEARTMATE 2
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 16996076
• MDR Text Key: 315914707
• Report Number: 16996076
• Device Sequence Number: 1
• Product Code: DSQ
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2023
• Distributor Facility Aware Date: 11/20/2021
• Device Age: 18 MO
• Event Location: Home
• Date Report to Manufacturer: 05/22/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male