MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER; LEFT VENTRICULAR SYSTEM CONTROLLER

Catalog Number 106762

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

The serial number of the system controller and the 11 volt li-ion backup battery were not provided, therefore the device unique identifier (udi), approximate age of device and manufacture date are not known.The patient remains on lvad support with no further issues reported.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2013.It was reported that family exchanged system controller due to backup battery fault alarm on (b)(6) 2018.The lvad clinicians re-educated the patient and the family about the process of system controller exchanges.Analysis of the submitted logs completed by the manufacturer¿s technical services representative revealed a backup battery fault alarm on (b)(6) 2018 at 12:00:00 am indicated that the internal backup battery exceeded its expiration date.The patient disconnected the driveline on (b)(6) 2018 at 1:22:35 pm.On (b)(6) 2018, it was reported that the backup battery fault alarm has resolved.No further information was provided.

Manufacturer Narrative

Correction event date changed from (b)(6) 2018 to (b)(6) 2018.The reported event of a backup battery fault alarm was confirmed during the analysis of the system controller log files provided for review.The system controller was not returned for evaluation and remains in use following the event.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: LEFT VENTRICULAR SYSTEM CONTROLLER
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 7264891
• MDR Text Key: 100009689
• Report Number: 2916596-2018-00546
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 106762
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2916596-9/14/15-001-C
• Patient Sequence Number: 1
• Treatment: 11 V LITHIUM-ION BACKUP BATTERY: UNKNOWN
• Patient Age: 73 YR
• Patient Weight: 53