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

Model Number	1103
Medical Device Problem Codes	Pumping Stopped (1503); Use of Device Problem (1670); Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
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: dtmb1qq icd implanted (b)(6) 2025.Additional products: d1: heartware ventricular assist system controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-jan-2024 serial #: (b)(6); d9: no.H3: no h4: mfg date: 03-jan-2023 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 review of log file data revealed a motor start event with parameters outside of the typical range.It was also reported that the ventricular assist device (vad) exhibited high power, and the patient experienced multiple pump stops due to double power disconnects.The vad coordinator reported that the patient is elderly and likely performs double power disconnects while changing power supplies, resulting in pump stops.The vad and 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 investigation summary.Additional product: serial# (b)(6) h3: yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.Product event summary: the ventricular assist device (vad) (b)(6) and the controller ((b)(6)) were not returned for evaluation.A review of the device history records was not performed as the reported event and analysis are not related to a manufacturing or servicing issue.Log file analysis revealed one (1) vad disconnect alarm logged on (b)(6) 2025 at 22:55:03, indicating a physical disconnection of the driveline from the controller.Review of the event file and available motor start report revealed two (2) motor start events recorded on (b)(6) 2025 at 09:07:34 and (b)(6) 2025 at 22:57:20, in which parameters were atypical.No anomalies were found involving (b)(6) within the analyzed period.As a result, the reported atypical motor start events and reported vad stop event was confirmed.Log file analysis revealed no controller power-up events, indicating a loss of power or double disconnection of power sources to the controller, within the analyzed period.As a result, the reported double disconnect event was not confirmed.However, the reported double disconnect event was likely refers to the vad stop event.In addition, log file analysis revealed power consumption was within normal operating range during the analyzed period.As a result, the reported high power event was not confirmed; however, the reported h igh power event likely refers to the atypical motor start event.Based on risk documentation, the most likely root cause of atypical motor start parameters may be attributed, but not limited, to outer shroud contact that creates more friction at the housing to imp eller interface during pump startup.The most likely root cause of the vad disconnect alarm, correlating the reported vad stop event, can be attributed to a physical disconnection of the driveline from the controller, as described in the reported event details.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 - PUMP
• 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: 23832282
• Report Number: 3007042319-2025-02532
• Device Sequence Number: 5080480
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: (01)00888707003261(17)201231
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (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): 02/05/2026

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: 12/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6935M62 ICD, 5076-52 LEAD, 5076-52 LEAD
• Patient Age: 79 YR
• Patient Sex: Male