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

Model Number 1650

Device Problems Battery Problem (2885); Power Problem (3010)

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

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Continuation of d10: ddpb3d1 icd implant date: (b)(6) 2021.5076-52 <(>&<)> 694765 leads implant date: (b)(6) 2011 additional products: d1: heartware ventricular assist system ¿ battery d4: model#: 1650 / catalog#: 1650 / expiration date: 30-sep-2024 / serial#: (b)(6).Udi#: (b)(4).D9: no h3: no, device evaluation anticipated, but not yet begun dev rtn to mfr? no h4: mfg date: 15-sep-2023 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.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 a battery exhibited a power disconnect alarm observed in log files.  it was also reported that the patient brought a battery into the clinic that had the word "bad" written on it with a sharpie. the batteries will be returned. no patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device analysis.Product event summary: two (2) 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 inspection and functional testing.Internal visual inspection of the batteries revealed no anomalies.Of note, the word "bad" was written on the battery housing of (b)(6).However, this did not impact the legibility of the battery labeling or damage the housing.Log file analysis revealed that the controller in use during the analyzed period ((b)(6)) contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Review of the alarm log file did not reveal any power disconnect alarms within the analyzed period; however, review of the data log file revealed two (2) instances involving (b)(6) where the battery¿s relative state of charge (rsoc) value was logged between 101-201, which is indicative of a communication error.As a result, the reported power disconnect alarm event was confirmed for (b)(6).The reported event associated with (b)(6) could not be confirmed.(b)(6) had been lubricated prior to release.Possible root causes of the communication errors, and resulting power disconnect alarms, can be attributed to momentary disconnections on the communication pins of the controller, the controller not receiving responses from the batteries, and/or due to the packet error checking method detecting bit errors.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was further reported that the controller and multiple batteries exhibited power switching.The patient described multiple single beeps when not reconnecting power sources (allegedly on the same side), and when moving around.A no power alarm occurred although connected to power sources.

Manufacturer Narrative

A supplemental report is being submitted for additional information was received.Additional products: d1: heartware ventricular assist system ¿ controller d4: model #: 1420 / catalog #: 1420 / expiration date: 30-sept-2019 / serial (b)(6) udi (b)(4) d9: no h3: no h4: mfg date: 07-sept-2018 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.Investigation of this event is pending and a supplemental report will be sent upon its completion.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18789350
• MDR Text Key: 336785076
• Report Number: 3007042319-2024-01088
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707009942
• UDI-Public: 00888707009942
• 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
• Report Date: 05/23/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: 1650
• Device Catalogue Number: 1650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 05/10/2024; 05/13/2024
• Supplement Dates FDA Received: 05/16/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2022
• 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: (B)(6)
• Patient Age: 48 YR
• Patient Sex: Male