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

Model Number 1420

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 07/08/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: brand name: heartware ventricular assist system ¿ battery, model #: 1650de / catalog #: 1650de / expiration date: 31-oct-2021 / serial #: (b)(4), udi #: (b)(4), device available for evaluation: no, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun, mfg date: 16-oct-2020, labeled for single use: no, (b)(4).Concomitant medical products: 693565 defib lead, implanted (b)(6) 2015 dtpb2d1, icd implanted (b)(6) 2020, 5076-45 non-defib lead, implanted (b)(6) 2020, 383069 non-defib lead, implanted (b)(6) 2020.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 there was an erroneous critical battery alarm in which the capacity read 25%, previous to the critical battery alarm.It was also reported there was a controller fault alarm due to the power being out of range.The battery was replaced by the patient and resolved the controller fault alarm.The controller remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: one (1) controller ((b)(6)) and one (1) battery ((b)(6)) were not returned for evaluation.Review of the battery's manufacturing documentation confirmed that the associated device met all requirements for release.Review of the alarm log file revealed a controller fault alarm logged on 08/jul/2022 at 19:08:54 due to a power out of range.During the controller fault alarm, (b)(6) was connected to power port one (1) with 74% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 25% rsoc.The controller fault alarm cleared at 19:08:56 and (b)(6) was not connected to power port two (2).Review of the alarm log file also revealed a critical battery alarm logged on 08/jul/2022 at 23:06:54 involving (b)(6).During the critical battery alarm the battery dropped from 25% rsoc to 0% rsoc.As a result, the reported event was confirmed.Applicable risk documentation and experience with events of similar circumstances were considered; the most likely root cause of the reported controller fault alarm event can be attributed to a power out of range condition, likely due to a battery malfunction.A possible root cause of reported critical battery alarm may be attributed, but not limited, to an estimation error, a soldering defect, or a welding defect.Additional products: d4: serial #: (b)(6), h3: yes h6: fda method code(s): b14,b15,b17 h6: fda results code(s): c02 h6: fda conclusion code(s): d15 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: 15069398
• MDR Text Key: 304784015
• Report Number: 3007042319-2022-06657
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2021
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2020
• 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: 68 YR
• Patient Sex: Female