MAUDE Adverse Event Report: THORATEC CORP/ ABBOTT LABORATORIES HEARTMATE 2 LVAD; VENTRICULAR (ASSIST) BYPASS

Device Problems Break (1069); Charging Problem (2892); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2021

Event Type  Injury  

Event Description

Patient states that he is having a problem with charging his backup controller-"it doesn't fit in the mpu." upon assessment of backup controller, pins look normal.Upon assessment of mpu, there appears to be a pin broken off and stuck into a connection.Upon inspection of the primary controller, there is a pin broken off.Primary controller changed in clinic.Mpu also taken out of service and replaced.Fda safety report id # (b)(4).

• Brand Name: HEARTMATE 2 LVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORP/ ABBOTT LABORATORIES
• MDR Report Key: 11974533
• MDR Text Key: 255632351
• Report Number: MW5101785
• Device Sequence Number: 1
• Product Code: DSQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• 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 Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR
• Patient Weight: 78