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

Model Number	1650
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that five (5) batteries exhibited an irregularity in which, when a battery was less than 25% the controller switched to the other power source, the low capacity battery then recovered one led more, showing a total of two.This was reported as an irregularity by the patient and had not been previously observed.The batteries remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional products: d1: heartware ventricular assist system ¿ battery d4: model #:1650/ catalog #:1650/ expiration date: 31-mar-2024/ serial or lot#: (b)(6) d9: no h3: no h4: mfg date: 22-mar-2023 h5: no d1: heartware ventricular assist system ¿ battery d4: model #:1650/ catalog #:1650/ expiration date: 31-mar-2024/ serial or lot#: (b)(6) d9: no h3: no h4: mfg date: 28-mar-2023 h5: no d1: heartware ventricular assist system ¿ battery d4: model #:1650/ catalog #:1650/ expiration date: 31-mar-2024/ serial or lot#: (b)(6) d9: no h3: no h4: mfg date: 28-mar-2023 h5: no d1: heartware ventricular assist system ¿ battery d4: model #:1650/ catalog #:1650/ expiration date: 31-oct-2024/ serial or lot#: (b)(6) d9: no h3: no h4: mfg date: 02-oct-2023 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event 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.
Additional Manufacturer Narrative
A supplemental report is being submitted for investigation summary.Additional products: serial# (b)(6) h3:yes serial# (b)(6) h3:yes serial# (b)(6) h3:yes serial# (b)(6) h3:yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.Product event summary: five (5) batteries ((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 abnormalities relating to the relative state of charge (rsoc) involving (b)(6), (b)(6), (b)(6), and (b)(6) within the analyzed period; the batteries were not estimating the capacity accurately, likely due to an estimation error.While these batteries were connected as passive batteries, (b)(6) changed from 23% to 24% rsoc on (b)(6) 2025 and on (b)(6) 2025, (b)(6) changed from 94% to 95% rsoc on (b)(6) 2025 and from 90% to 91% rsoc on (b)(6) 2025 and (b)(6) changed from 24% to 26% rsoc on (b)(6) 2025 and from 22% to 23% rsoc on (b)(6) 2025.Additionally, (b)(6) changed from 21% to 22% rsoc on (b)(6) 2025, from 22% to 23% rsoc on (b)(6) 2025 and from 24% to 25% rsoc on (b)(6) 2025.The change in (b)(6) from 24% to 26% rsoc on (b)(6) 2025 would cause the battery light indicator to go from one (1) led to two (2) leds.Review of the controller log files revealed no anom alies involving (b)(6) within the analyzed period.In addition, no power switching events were logged within the analyzed period.As a result, the reported abnormal battery behavior was confirmed.The reported power switching event could not be confirmed.However, the reported abnormal battery behavior was likely perceived as the reported power switching event.Based on risk documentation and historical review of similar events, the most likely root cause of the reported abnormal battery behavior event can be attributed to an estimation error.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 - BATTERY
• 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: 23878134
• Report Number: 3007042319-2025-02549
• Device Sequence Number: 18507669
• Product Code: DSQ
• UDI-Device Identifier: 00763000629717
• UDI-Public: (01)00763000629717(17)240331
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• 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: 03/31/2024
• Device Model Number: 1650
• Device Catalogue Number: 1650
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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: Female