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

Model Number	1650
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report is being submitted for analysis and investigation completion.Product event summary: the battery (bat (b)(6) was returned for evaluation.A review of the manufacturing records confirmed that the associated device met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Log file analysis did not reveal any anomalies; the available data log file did not cover the reported event date.Failure analysis of the returned battery revealed that the device passed visual inspection.Functional testing revealed that the battery was unable to charge or provide power due to an enabled zero-volt charge (zvchg) field-effect transistor (fet).An internal visual inspection did not reveal any anomalies.The gas gauge is not programmed to use the zvchg fet, which indicates that the battery unintentionally enabled the fet.The zvchg fet disables the charge and discharge fets, rendering the battery inoperable; this results in the inability to illuminate the battery status leds on the controller display when a battery is connected to the controller.As a result, the reported event was confirmed.Based on an investigation conducted under capa (b)(4) , the most likely root cause of the observed inability of the battery to charge or provide power event has been attributed to the battery connector interface design which does not guarantee the desired connection angle in some use conditions.Bat (b)(6) is in scope of fa1265, which was initiated for batteries with electrical faults.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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the battery exhibited a display error.When a fully charged battery was connected to the controller, the battery charge capacity indicator will not display the battery led bars.The battery was removed from service. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted for correction to d4 unique device identifier (udi).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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18271934
• Report Number: 3007042319-2023-04657
• Device Sequence Number: 3905174
• Product Code: DSQ
• UDI-Device Identifier: 00888707008778
• UDI-Public: (01)00888707008778(17)221130(2
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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: 1650
• Device Catalogue Number: 1650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1512-2022
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 74 KG