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

Device Problems Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986)

Patient Problem Insufficient Information (4580)

Event Date 05/31/2020

Event Type  Injury  

Event Description

Patient went to (b)(6) ed (b)(6) 2020 due to vad alarms.While at the beach battery pack became wet while patient standing knee deep in ocean.No dysfunction of vad noted.Needed items 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: 12624319
• MDR Text Key: 276446412
• Report Number: 12624319
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/31/2020
• Device Age: 18 MO
• Event Location: Home
• Date Report to Manufacturer: 09/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR