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

Device Problems Loose or Intermittent Connection (1371); Battery Problem (2885); Patient Device Interaction Problem (4001)

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

Event Date 02/21/2022

Event Type  Injury  

Event Description

Patient arrived to clinic (b)(6) 2022 with intermittent low voltage alarms while on clips.Reports having to clean his clips and batteries monthly.Battery clips examined and seem loose.Battery clips replaced.

• Brand Name: HEARTMATE 3
• Type of Device: LEFT VENTRICULAR DEVICE CABLE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge dr.; pleasanton CA 94588
• MDR Report Key: 16485461
• MDR Text Key: 310784727
• Report Number: 16485461
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2023
• Distributor Facility Aware Date: 02/21/2022
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 03/02/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 106 KG