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

Model Number	1403
Medical Device Problem Codes	Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.  continuation of d10: additional products: d1: heartware ventricular assist system controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: unknown / serial or lot#: (b)(6) (c) d9: no h3: no h4: mfg date: unknown h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.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 a controller exhibited a controller fault alarm due to a depleted internal battery.The patient was admitted to hospital and the controller fault alarm was silenced.The site planned and successfully performed a controller exchange.During the exchange to the new controller a loss of power was noted.The vad remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted for device evaluation.Product event summary: two (2) controllers ((b)(6)) were not returned for evaluation.A review of the manufacturing documentation was not performed as the reported event and analysis are not related to a manufacturing or a servicing issue.Log file analysis associated with con415008 revealed two (2) controller fault alarm events logged on (b)(6) 2025 at 19:38:35 and on (b)(6) 2025 at 00:08:29, 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.Log file analysis associated with (b)(6) revealed a controller power up event with an associated pump start event was logged on (b)(6) 2025 at 10:30:39.Various parameters, including time, patient id, and pump id were programmed on (b)(6) 2025 prior to the controller power up event, indicating the power up event occurred during the initial programming of the controller and/or a controller exchange.The alarm log file associated with (b)(6) was not available for analysis.Of note, (b)(6) was loaded with a software containing the pump start algorithm c.As a result, the reported events were confirmed.Applicable risk documentation, experience with events of similar circumstances, and the available information were considered; possible root causes of the controller fault alarms may be attributed, but not limited, to a reduced charge capacity of the internal battery and/or a faulty internal battery charger integrated circuit.Based on the available information, the most likely root cause of the controller power-up event associated with (b)(6) can be attributed to the initial programming of the controller and/or a controller exchange.Additional products: d1: controller d4: (b)(6).H3: yes.H6: the codes present in section h6 correspond to components/products that comprise the reported event.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: 23975720
• Report Number: 3007042319-2026-00014
• Device Sequence Number: 21489373
• Product Code: DSQ
• UDI-Device Identifier: 00888707006859
• UDI-Public: (01)00888707006859(17)220131
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: 1403
• Device Catalogue Number: 1403
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2021
• 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: 1103 VAD.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female