MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS

Model Number	1420
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the controller exhibited a controller fault alarm due to an internal battery end of life.The alarm was currently muted, and the clinic planned to discuss an exchange.The controller remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted for additional information.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was further reported that the controller was exchanged.
Additional Manufacturer Narrative
A supplemental report is being submitted for device evaluation.Product event summary: the controller ((b)(6)) was not returned for evaluation.Review of the device history record confirmed that the associated device met all requirements for release.Log file analysis associated with (b)(6) revealed two (2) controller fault alarms logged on (b)(6) 2025 at 10:48:19 and at 13:06:34, indicating an issue with the internal battery.In addition, log files revealed that the controller had been in use for more than two (2) years.Additionally, log file analysis associated with (b)(6) revealed a controller power-up event, with an associated pump start event, logged on (b)(6) 2025 at 14:19:53.Analysis of the event log file revealed that the date, pump id, and alarm limits were being set prior to the controller power up event.Additionally, review of the data log file revealed that the controller was not in use prior to the controller power up event; the first data point was logged on (b)(6) 2025 at 14:20:29, indicating that the controller power up likely occurred during the initial programming of the controller and/or a controller exchange.Review of the alarm file revealed one (1) vad disconnect alarm logged on (b)(6) 2025 at 14:20:01, indicating that the controller was powered on without the driveline connected.The alarm cleared at 14:20:22, indicating that the driveline was connected.As a result, the reported event was confirmed.Based on the available information, the most likely root cause of the reported loss of power event can be attributed to the initial programming of the controller and/or the reported controller exchange.Applicable risk documentation, experience with events of similar circumstances, and the available information were considered; possible root causes of the reported controller fault alarm event may be attributed, but not limited, to a reduced charge capacity of the internal battery and/or a faulty internal battery charger integrated circuit.The most likely root cause of the vad disconnect alarm can be attributed to the controller being powered on without the driveline connected, likely during the reported controller exchange.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 23696738
• Report Number: 3007042319-2025-02489
• Device Sequence Number: 13310036
• Product Code: DSQ
• UDI-Device Identifier: 00888707007658
• UDI-Public: (01)00888707007658(17)220331
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2026

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 Expiration Date: 03/31/2022
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 01/07/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/04/2025; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1104 VAD.
• Patient Sex: Unknown