MAUDE Adverse Event Report: THORATEC CORP. HEARTMATE II SYSTEM CONTROLLER; DSQ: LVAD SYSTEM CONTROLLER

Model Number 103696

Device Problems Disconnection (1171); Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Fall (1848); Complaint, Ill-Defined (2331)

Event Date 02/10/2014

Event Type  Death  

Event Description

The patient was implanted with a left ventricular assist device.The vad coordinator reported that the nurse walked in to find the patient expired.It appeared that the patient fell from his wheelchair.He was plugged into the power base unit, cables wrapped around his legs, and the cord from his controller was disconnected.Patient reportedly struck his head on the wall, with a partially dried pool of blood on the floor.Emergency medical services were called and the patient was pronounced dead.The patient expired at home and there was no autopsy.Neither the pump nor the system controller were returned.

Manufacturer Narrative

No further information is available at this time.A supplemental report will be submitted when the manufacturer's investigation is completed.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: DSQ: LVAD SYSTEM CONTROLLER
• Manufacturer (Section D): THORATEC CORP.; pleasanton CA
• Manufacturer (Section G): THORATEC CORP.; 6035 stoneridge dr.; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth ave.; burlington, MA 01803 ; 7812720139
• MDR Report Key: 3928818
• MDR Text Key: 4603615
• Report Number: 2916596-2014-01000
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2014

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
• Device Expiration Date: 08/30/2015
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Device Lot Number: 118060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/10/2014
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 05/27/2014
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 115