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

Model Number	1650DE
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Concomitant medical products: 1103 vad implanted: (b)(6) 2016 and dtmb1d4 icd implanted: (b)(6) 2017.Additional products: heartware ventricular assist system ¿ battery; model #: 1650de / catalog #: 1650de / expiration date: 31-mar-2019 / serial #: (b)(4), udi #: (b)(4), no, mfg date: 23-mar-2018, no, (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the batteries were power switching multiple times when hooked up to the controller along with single beeps.The batteries were replaced.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: the batteries 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.Controller log files were not available for analysis.Failure analysis of the returned devices revealed that the batteries passed visual inspection and functional testing.The reported event could not be duplicated during bench testing; the batteries did not experience a power switching event and were able to adequately provide power to a test controller.As a result the reported event could not be confirmed.A power source lubrication procedure was performed on the reported devices in accordance with the requirements on (b)(6) 2018.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported premature power switching event after lubrication can be attributed, but not limited to a communication error and/or momentary disconnection due to temporary corrosion of the controller-port/power-source pins.However, the reported beeps are most likely attributed to momentary disconnections due to temporary corrosion of the controller-port/power-source pins.Additional products: bat751332 h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 67 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: 9571860
• Report Number: 3007042319-2020-00084
• Device Sequence Number: 19322833
• Product Code: DSQ
• UDI-Device Identifier: 00888707002646
• UDI-Public: 00888707002646
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: 03/31/2019
• Device Model Number: 1650DE
• Device Catalogue Number: 1650DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1903-2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 429688 LEAD, 6947M62 LEAD, 5076-52 LEAD
• Patient Age: 65 YR
• Patient Weight: 85