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

Device Problems Low Audible Alarm (1016); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2021

Event Type  Injury  

Event Description

Patient seen during tele-visit on (b)(6) 2021 and reported a concern of vad low alarm on sunday night and controller cord problem with message alarm of, "power cable disconnected" but it is connected securely.She reset alarms by disconnecting and connecting cables.Replacement power module cable sent.

Event Description

Patient seen during tele-visit on (b)(6) 2021 and reported a concern of vad low alarm on sunday night and controller cord problem with message alarm of, "power cable disconnected" but it is connected securely.She reset alarms by disconnecting and connecting cables.Replacement power module cable sent.

• Brand Name: HEARTMATE II
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge dr.; pleasanton CA 94588
• MDR Report Key: 13585652
• MDR Text Key: 286081957
• Report Number: 13585652
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2022
• Distributor Facility Aware Date: 02/10/2021
• Device Age: 6 YR
• Event Location: Home
• Date Report to Manufacturer: 02/07/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female