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

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 09/14/2020

Event Type  Injury  

Event Description

During office visit on (b)(6) 2020 it was noted on the controller screen that the lower part of display is not visible during parameter check.Controller replaced by vad team.

• Brand Name: HEARTMATE III
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION ; 6035 stoneridge dr. ; pleasanton CA 94588
• MDR Report Key: 12624303
• MDR Text Key: 276446101
• Report Number: 12624303
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2021
• Distributor Facility Aware Date: 09/14/2020
• Device Age: 18 MO
• Date Report to Manufacturer: 09/29/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR