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

Model Number 1420

Device Problems Electrical /Electronic Property Problem (1198); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Concomitant medical products: 407652, and 6947m55 leads & ddmc3d4 icd, implant date: (b)(6) 2017.Additional products: brand name: heartware ventricular assist system ¿ battery, model#: 1650, catalog #: 1650, expiration date: 31-jan-2021, serial#: (b)(4), udi #: (b)(4), device available for evaluation: no, no, device evaluation anticipated, but not yet begun analysis.Mfg date: 03-jan-2020, labeled for single use: no, patient ime code(s): (b)(4).Brand name: heartware ventricular assist system ¿ battery, model#: 1650, catalog #: 1650, expiration date: 31-jan-2021, serial#: (b)(4), device available for evaluation: no, no, device evaluation anticipated, but not yet begun analysis, mfg date: 04-jan-2020, labeled for single use: no, (b)(4).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 Description

It was reported that the controller exhibited multiple controller fault alarms attributed to "power out of range" associated with two specific batteries.The controller remains in use and the batteries will be replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device analysis.Product event summary: one (1) controller (b)(6) and two (2) batteries (b)(6) were not returned for evaluation.Log file analysis associated with (b)(6) revealed three (3) controller fault alarms were logged on 19-jul-2022 at 22:06:11, 22:06:21 and 22:07:50.Leading up to the first controller fault alarm, (b)(6) was the secondary power source and (b)(6) was the primary power source.Controller fault alarms were recorded when (b)(6) approached 24% relative state of charge (rsoc), at which point the controller switched to (b)(6) as the primary power source with 100% rsoc.Review of the data log file revealed that (b)(6) had been used as either the primary power source or the secondary power source since 18-jul-2022 at 18:11:54.Within the analyzed period that the (b)(6) was being used, it was reporting a rsoc value of 100%.Since the reported rsoc value did not decrease, the controller didn¿t switch to the secondary power source and no low battery or critical battery alarms were triggered to alert th e patient to replace the battery, and the battery was allowed to continue to deplete.A controller fault alarm will be triggered if a battery is approaching 0% rsoc.As a result, the reported event was confirmed.Based on an investigation conducted under capa pr00519785, the most likely root cause of the reported controller fault alarms event has been attributed to the battery connector interface design which does not guarantee the desired connection angle in some use conditions, resulting in the battery reporting a frozen rsoc value while powering the controller, thus resulting in the battery being allowed to deplete completely.Additional products: d4: serial or lot#: (b)(6) h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c02 h6: fda conclusion code(s): d01 d4: serial or lot#: (b)(6) h3: yes h6: fda method code(s): b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 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.

• 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: 15114484
• MDR Text Key: 304630706
• Report Number: 3007042319-2022-06738
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707006859
• UDI-Public: 00888707006859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 1103 VAD
• Patient Age: 22 YR
• Patient Sex: Male