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

Model Number	1650DE
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was further reported that the manufacturer received product performance data.Manufacturer's analysis subsequently revealed that the battery exhibited a critical battery alarm due to communication error.The battery remains in use.
Additional Manufacturer Narrative
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.Product event summary: the battery (bat(b)(6) was 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.No performance allegations were made against bat(b)(6); therefore, the purpose of this investigation is solely to address the finding identified during analysis of the controller log files.Log file analysis revealed that the controller in use during the reported event, (b)(6), contained a software with 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 revealed one (1) critical battery alarm due to a communication error on (b)(6) 2024 at 00:39:51 involving bat(b)(6).As a result, the finding was confirmed.The battery had been lubricated prior to release.The most likely root cause of the critical battery alarm can be attributed to a communication error between the controller and the battery.Possible root causes of the communication error 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.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: 20506661
• Report Number: 3007042319-2024-04688
• Device Sequence Number: 8209928
• Product Code: DSQ
• UDI-Device Identifier: 00888707008778
• UDI-Public: (01)00888707008778(17)221130(2
• Combination Product (Y/N): N
• 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): 12/27/2024

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: 11/30/2022
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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: (B)(6)
• Patient Age: 55 YR
• Patient Sex: Male