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	06/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented to the hospital with complaints of power disconnect alarms and erroneous critical battery alarms while using their controller.Upon reviewing the log files, it was discovered that several batteries that should not have been in use were used.The site replaced two of the batteries with new ones, and the four remaining batteries were promptly removed and properly disposed of.It was also decided not to change the controller at this time unless further issues arise.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.H6: the codes present in section h6 correspond to components/products that comprise the reported event.Additional products: d1: heartware ventricular assist system - battery d4: model#: 1650 / catalog#: 1650 / expiration date: 31-aug-2024 / serial #: (b)(6) d9: no h3: no h4: mfg date: 5-aug-2023 h5: no d1: heartware ventricular assist system - battery d4: model#: 1650 / catalog#: 1650 / expiration date: 30-april-2023 / serial#: (b)(6) d9: no h3: no h4: mfg date: 25-april-2022 h5: no d1: heartware ventricular assist system - battery d4: model#: 1650 / catalog#: 1650 / expiration date: 30-april-2023 / serial#: (b)(6) d9: no h3: no h4: mfg date: 25-april-2022 h5: no d1: heartware ventricular assist system - battery d4: model#: 1650 / catalog#: 1650 / expiration date: 31-jan-2023 / serial#: (b)(6) h3: no h4: mfg date: 26-jan-2022 h5: no d1: heartware ventricular assist system - battery d4: model#: 1650 / catalog#: 1650 / expiration date: 30-april-2023 / serial#: (b)(6) h3: no h4: mfg date: 14-april-2022 h5: no.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 analysis and investigation completion.Product event summary: one (1) battery ((b)(6)) was returned for evaluation.Five (5) batteries ((b)(6), (b)(6), (b)(6), (b)(6), (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 servicing issue.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned battery revealed that the device passed visual inspection and functional testing.An internal inspection did not reveal any anomalies.Log file analysis revealed that the controller in use during the reported event ((b)(6)) contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the alarm log file did not reveal any power disconnect alarms within the analyzed period; however, review of the data log file revealed multiple instances involving (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), and (b)(6) where the batteries¿ relative state of charge (rsoc) value was logged between 101-201, which is indicative of communication errors.A communication error will trigger a power disconnect alarm if the other power source is a power adapter or a battery with an rsoc greater than (b)(4).Additionally, review of the alarm log file revealed five (5) critical battery alarms were logged between (b)(6) 2025 and (b)(6) 2025 due to communication errors involving (b)(6), (b)(6), (b)(6), and (b)(6).As a result, the reported events were confirmed.The batteries had been lubricated prior to release.Possible root causes of the communication errors and resulting power disconnect alarms, can be attributed to momentary disconnections on the communication pins of the controller, the controller not receiving responses from the batteries, and/or due to the packet error checking method detecting bit errors.The most likely root cause of the reported critical battery alarm events can be attributed to a communication error between the controller and the battery.Additional product: d1: heartware ventricular assist system ¿ battery d4: serial #: (b)(6) h3: yes d1: heartware ventricular assist system ¿ battery d4: serial #: (b)(6) d9: yes, return date: 22-jul-2025 h3: yes d1: heartware ventricular assist system ¿ battery d4: serial #: (b)(6) h3: yes d1: heartware ventricular assist system ¿ battery d4: serial #: (b)(6) h3: yes d1: heartware ventricular assist system ¿ battery d4: serial #: (b)(6) h3: yes d1: heartware ventricular assist system ¿ battery d4: serial #: (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 - 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: 22383180
• Report Number: 3007042319-2025-01398
• Device Sequence Number: 7138179
• Product Code: DSQ
• UDI-Device Identifier: 00763000629717
• UDI-Public: (01)00763000629717(17)240831
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 08/11/2025

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: 08/31/2024
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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: (B)(6).
• Patient Age: 59 YR
• Patient Sex: Male