MAUDE Adverse Event Report: Thoratec Corporation THORATEC® HEARTMATE II®, SYSTEM CONTROLLER; Ventricular (Assist) Bypass

Model Number	106762
Medical Device Problem Codes	Premature Discharge of Battery (1057); Disconnection (1171); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had multiple low voltage advisory alarms and stated that their batteries were not draining equally.The battery connected to the white cable on the system controller was draining much faster.The patient cleaned all peripheral equipment and changed their batteries and battery clips, but the alarms did not resolve.The alarms continued to occur on all batteries and different sets of battery clips.Log files were submitted.Upon review, the heartmate 2 log files recorded 228 low battery advisory events on 14sep2026 from 2:27:13pm to 4:32 pm.The low battery hazard advisory events were recorded at times when the white power lead was disconnected.A root cause for the event was not able to be determined based on the log files.Follow-up from the customer reported that the patient's primary pocket controller was successfully exchanged and the alarms had resolved.The patient would continue to be monitored.
Additional Manufacturer Narrative
Section d4: device expiration date cannot be determined.The udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER
• Common Device Name: Ventricular (Assist) Bypass
• Manufacturer (Section D): Thoratec Corporation; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): Thoratec Corporation; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; +1(781)852-8207
• MDR Report Key: 50888561
• Report Number: 2916596-2026-2919992
• Device Sequence Number: 9792057
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 134 LB