MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE-CTRL BTT-11V LI-ION; HEARTMATE-CTRL 11V LI-ION BATTERY

Catalog Number 106128

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

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

Event Date 04/08/2018

Event Type  malfunction  

Manufacturer Narrative

The serial number of the device was requested but was not provided, therefore the expiration date, manufacture date and device unique identifier (udi) are unknown.Approximate age of device- 2 years and 8 months (calculated from the date the battery was assigned to the patient) the patient remains ongoing with the lvad device.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) 2015.It was reported that the patient presented with backup battery fault events observed on the system controller.The backup battery fault was associated with the expiration date.No further information was provided.

• Brand Name: HEARTMATE-CTRL BTT-11V LI-ION
• Type of Device: HEARTMATE-CTRL 11V LI-ION BATTERY
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7491916
• MDR Text Key: 107580838
• Report Number: 2916596-2018-01675
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 106128
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 91