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

Model Number	1650
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.The event date was unable to be obtained through follow-up.The date provided is the best estimated event date based on information within the event.Additional products: heartware ventricular assist system  battery model #: 1650de / catalog #: 1650de / expiration date: 31-may-2019/ serial#: (b)(4) udi #: (b)(4) device evaluated: no.No, device evaluation anticipated, but not yet begun mfg date: 04-may-2018 labeled for single use: no.(b)(4).Heartware ventricular assist system  battery model #: 1650de / catalog #: 1650de / expiration date: 31-may-2019/ serial#: (b)(4) udi #: (b)(4) device evaluated: no.No, device evaluation anticipated, but not yet begun mfg date: 04-may-2018 labeled for single use: no.(b)(4).Heartware ventricular assist system  battery model #: 1650de / catalog #: 1650de / expiration date: 31-may-2019/ serial#: (b)(4) udi #: (b)(4) device evaluated: no.No, device evaluation anticipated, but not yet begun mfg date: 04-may-2018 labeled for single use: no.(b)(4).Heartware ventricular assist system  battery model #: 1650de / catalog #: 1650de / expiration date: 31-may-2019/ serial#: (b)(4) udi #: (b)(4) device evaluated: no.No, device evaluation anticipated, but not yet begun mfg date: 04-may-2018 labeled for single use: no.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that one of the batteries exhibited critical battery alarms, though it could not be determined which specific battery exhibited the alarms.The batteries were exchanged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted for device evaluation.Product event summary: five (5) batteries were not returned for evaluation.Review of the controller log files associated with the c ontroller in use at the time revealed one (1) critical battery alarm involving bat753298 on 31-dec-2020 due to the battery depleting below 10% relative state of charge (rsoc).As a result, the reported event was confirmed.The most likely root cause of the reported event can be attributed to the patient allowing the battery to deplete below 10%, triggering a critical battery alarm.Additional products: d1: heartware ventricular assist system battery d4: serial#:(b)(6).H3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d1: heartware ventricular assist system battery d4: serial#: (b)(6).H3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d1: heartware ventricular assist system battery d4: serial#: (b)(6).H3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d1: heartware ventricular assist system battery d4: serial#: (b)(6).H3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d11 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 - BATTERY
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 11297721
• Report Number: 3007042319-2021-00591
• Device Sequence Number: 14386928
• Product Code: DSQ
• UDI-Device Identifier: 00888707002646
• UDI-Public: 00888707002646
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Model Number: 1650
• Device Catalogue Number: 1650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1103 VAD
• Patient Age: 45 YR