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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2020

Event Type  Injury  

Event Description

During patient clinic visit on (b)(6) 2020, an extensive amount of tape was noted to external portion of driveline.It was also noted pt had a short-to-shield so has an undergrounded cable when not on battery support.

• Brand Name: HEARTMATE II
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION ; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12365491
• MDR Text Key: 268236327
• Report Number: 12365491
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/16/2021
• Distributor Facility Aware Date: 11/11/2020
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 08/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 80