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

Model Number 1650

Device Problem Battery Problem (2885)

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

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Concomitant medical products: dtba1d1 crt-d implanted: (b)(6) 2015, 407652 lead implanted: (b)(6) 2010, 694765 lead implanted: (b)(6) 2010, 419688 lead implanted (b)(6) 2010 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 battery was not charging.The battery did not charge all the way displaying only two lights and died too quickly.The battery was replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for investigation summary.Product event summary: the battery (b)(6) was not returned for evaluation.Review of the manufacturing documentation confirmed that the battery met all requirements for release.Log file analysis was not conducted since log files were not available.As a result, the reported event could not be confirmed.Applicable risk documentation and experience with events of similar circumstances were considered; events involving batteries with power consumption issues can be attributed to soldering or welding defects.Events involving a battery not charging may be attributed, but not limited, to an internal battery communication error, a faulty integrated circuit, improper weld, soldering defect, out of temperature range, and/or a charge time-out of eight (8) hours.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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
• 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: 15105454
• MDR Text Key: 304106613
• Report Number: 3007042319-2022-06723
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707008778
• UDI-Public: 00888707008778
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: 1650
• Device Catalogue Number: 1650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• Date Device Manufactured: 08/23/2021
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 90 KG