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

Model Number 1420

Device Problems Battery Problem (2885); Appropriate Term/Code Not Available (3191)

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

Event Date 06/11/2023

Event Type  malfunction  

Event Description

It was reported that the patient heard "two tone alarm go off that sounds like an ambulance.When (they are) sitting in bed in the morning." the patient noted that they heard these alarms with all of their batteries.The controller and batteries were exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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, serial or lot#: unk.D9: no.H5: no.D1: heartware ventricular assist system ¿ battery.D4: serial or lot#: unk.D9: no.H5: no.D1: heartware ventricular assist system ¿ battery.D4: serial or lot#: unk.D9: no.H5: no.D1: heartware ventricular assist system ¿ battery.D4: serial or lot#: unk.D9: no.No d1: heartware ventricular assist system ¿ battery.D4: serial or lot#: unk.D9: no.H5: no.D1: heartware ventricular assist system ¿ battery d4: serial or lot#: unk.D9: no.H5: no investigation of this event is pending and a supplemental report will be sent upon its completion.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.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.

Manufacturer Narrative

A supplemental report is being submitted for a correction to h10 addt manufacturer for mdr product event summary: six (6) batteries ((b)(6)) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned devices revealed that the batteries passed visual examination and functional testing.The batteries were able to adequately charge and provide power to a test controller with no anomalies observed.Internal inspection of the batteries did not reveal any anomalies.Review of the controller log files could not be performed since log files were not available for analysis.As a result, the reported event could not be confirmed.The battery was lubricated prior to release.A possible root cause of the reported event may be attributed but not limited to communication errors.H6: the codes present in section h6 correspond to components/products that comprise the reported event.Additional products: d1: battery d4: serial#: (b)(6) d9: yes, return date: 19-july-2023 h3: yes d1: battery d4: serial#: (b)(6) d9: yes, return date: 19-july-2023 h3: yes d1: battery d4: serial#: (b)(6) d9: yes, return date: 19-july-2023 h3: yes d1: battery d4: serial#: (b)(6) d9: yes, return date: 19-july-2023 h3: yes d1: battery d4: serial#: (b)(6) d9: yes, return date: 19-july-2023 h3: yes d1: battery d4: serial#: (b)(6) d9: yes, return date: 19-july-2023 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 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.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 further reported that the batteries were exchanged and the controller has no allegation.

Manufacturer Narrative

A supplemental report is being submitted for additional information and corrections.Additional information: additional products: d1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 31-dec-2023 / serial #: (b)(6); udi #: (b)(4).D9: yes, return date: 19-jul-2023 h3: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes h4: mfg date: 23-dec-2022 d1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 31-dec-2023 / serial #: (b)(6); udi #: (b)(4).D9: yes, return date: 19-jul-2023 h3: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes h4: mfg date: 22-dec-2022 d1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 31-dec-2023 / serial #: (b)(6); udi #: (b)(4).Yes, return date: 19-jul-2023 h3: no, device evaluation anticipated, but not yet begun de v rtn to mfr? yes h4: mfg date: 22-dec-2022 d1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 31-dec-2023 / serial #: (b)(6); udi #: (b)(4).Yes, return date: 19-jul-2023 h3: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes h4: mfg date: 23-dec-2022 d1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 31-dec-2023 / serial #:(b)(6); udi #: (b)(4).Yes, return date: 19-jul-2023 no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes h4: mfg date: 22-dec-2022 d1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 31-dec-2023 / serial #: (b)(6); udi #: (b)(4).Yes, return date: 19-jul-2023 h3: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes h4: mfg date: 22-dec-2022 corrections: correction to b5.Additional review of the event and/or additional information received shows that there is no information to reasonably suggest that the controller in this report may have caused or contributed to a death or serious injury or that the controller in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.Investigation of this event is pending and a supplemental report will be sent upon its completion.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.

Manufacturer Narrative

A supplemental report is being submitted for a revision to the product event summary.Revised product event summary: the controller (b)(6) was not returned for evaluation.Log file analysis revealed multiple controller power up events with associated motor start events recorded between 13-apr-2021 and 05may-2021.The controller can only store a maximum of 30 days of data.After reaching the limit, the controller initiates a first-in first-out method whereby the oldest data point is deleted to allow the newest data point to be recorded.As a result, data logs covering the reported losses of power were not available.The controller was without power for an average of 17 seconds per loss of power.As a result, the reported event was confirmed.The most likely root cause of the losses of power can be attributed to the reported disconnection of both power sources from the controller, as described in the event details.Capa pr00551638 is investigating controller losses of power.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: 17217994
• MDR Text Key: 318023053
• Report Number: 3007042319-2023-02513
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2019
• 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: 71 YR
• Patient Sex: Male