MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II; VENTRICULAR (ASSIST) BYPASS

Model Number 105109

Device Problems Circuit Failure (1089); Disconnection (1171); Nonstandard Device (1420)

Patient Problem Death (1802)

Event Date 07/24/2017

Event Type  Death  

Event Description

Reporter stated found husband on the floor death after coming home from work on (b)(6) 2017.Device indicated disconnected but it was not disconnected stated reporter.Reporter believed device had short circuited.Reported also stated, husband particular device model was recalled back in 2017.

• Brand Name: HEARTMATE II
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION
• MDR Report Key: 9097811
• MDR Text Key: 159583919
• Report Number: MW5089910
• 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: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 105109
• Device Catalogue Number: 105109
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR