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

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 pt in clinic due to vad alarm.Replaced modular cable and controller.Pt came back to clinic (b)(6) 2020 due to re-occurence of vad alarms.Examination of vad and peripherals at this time indicated that water may have gotten inside the modular cable connector.Modular cable exchanged.

• 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: 12307147
• MDR Text Key: 266231500
• Report Number: 12307147
• 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: 02/26/2021

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: 08/09/2021
• Distributor Facility Aware Date: 10/20/2020
• Device Age: 18 MO
• Event Location: Home
• Date Report to Manufacturer: 08/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 91