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

Model Number	1650DE
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
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: 15-aug-2023 h5: no d1: heartware ventricular assist system - battery d4: model#: 1650 / catalog#: 1650 / expiration date: 31-mar-2024 / serial#: (b)(6) d9: no h3: no h4: mfg date: 21-mar-2023 h5: no d1: heartware ventricular assist system - battery d4: model#: 1650 / catalog#: 1650 / expiration date: 31-mar-2024 / serial#: (b)(6) d9: no h3: no h4: mfg date: 29-mar-2023 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.
Event or Problem Description
It was reported that a review of log file data revealed the batteries exhibited a communication error.The batteries 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: four (4) batteries (b)(6) were not returned for evaluation.A review of the manufacturing documentation confirmed that the associated batteries met all requirements for release.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.Review of the alarm log file revealed five (5) critical battery alarms due to communication errors logged on (b)(6) 2024 at 19:03:17 involving (b)(6), on (b)(6) 2024 at 07:49:52 involving (b)(6), on (b)(6) 2024 at 18:24:15 involving (b)(6), on (b)(6) 2024 at 05:46:42 and on (b)(6) 2025 at 15:24:03 involving (b)(6).As a result, the reported event was confirmed.The batteries were lubricated prior to release.The most likely root cause of the critical battery alarms can be attributed to communication errors between the controller and the battery.Possible root causes of the communication errors can be attributed to momentary disconnections on the communication pins of the controller, the controller not receiving responses from the battery, and/or due to the packet error checking method detecting bit errors.H6: the codes present in section h6 correspond to components/products that comprise the reported event.Additional products: d1: battery d4: (b)(6).H3: yes d1: battery d4: (b)(6).H3: yes d1: battery d4: (b)(6).H3: yes, 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: 22796044
• Report Number: 3007042319-2025-01912
• Device Sequence Number: 12922520
• Product Code: DSQ
• UDI-Device Identifier: 00763000629717
• UDI-Public: (01)00763000629717(17)240331
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 03/31/2024
• Device Model Number: 1650DE
• Device Catalogue Number: 1650DE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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: Unknown