MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3; LEFT VENTRICULAR ASSIST DEVICE

Device Problem Break (1069)

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

Event Date 12/18/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 new backup controller issued due to damage to black battery cable.

• Brand Name: HEARTMATE 3
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge dr.; pleasanton CA 94588
• MDR Report Key: 15105271
• MDR Text Key: 296651534
• Report Number: 15105271
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2022
• Distributor Facility Aware Date: 12/18/2020
• Device Age: 6 MO
• Date Report to Manufacturer: 07/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male