MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS

Model Number 1420

Device Problems Use of Device Problem (1670); Battery Problem (2885)

Patient Problem Loss of consciousness (2418)

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that the controller exhibited two unexpected losses of power, which were attributed to the patient mistakenly disconnecting both power sources from the controller.It was noted that the patient was suspected to have dementia.During the first loss of power to the controller, it was reported that the patient lost consciousness.Once the controller was reconnected, the patient regained consciousness.It was further reported that the controller had also exhibited two controller fault alarms, which were attributed to depletion of the internal battery.Due to concern regarding a controller exchange, the alarm was permanently silenced.The controller remains in use. no further patient complications have been reported as a result of this event.

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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• Type of Device: 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: 19033679
• MDR Text Key: 339262096
• Report Number: 3007042319-2024-01507
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000420
• UDI-Public: 00888707000420
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 1104 VAD
• Patient Age: 81 YR
• Patient Sex: Male