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Additional products: model #: 1650 / catalog #: 1650 / expiration date: 31-jul-2019 / serial #: (b)(4) udi #: (b)(4) device evaluated: no.No, device evaluation anticipated, but not yet begun mfg date: 20-jul-2018 labeled for single use: no (b)(4).Heartware ventricular assist system battery model #: 1650 / catalog #: 1650 / expiration date: 31-jul-2019 / serial #: (b)(4) udi #: (b)(4) device evaluated: no.No, device evaluation anticipated, but not yet begun mfg date: 20-jul-2018 labeled for single use: no (b)(4).Heartware ventricular assist system battery model #: 1650 / catalog #: 1650 / expiration date: 31-oct-2019 / serial #: (b)(4) udi #: (b)(4) device evaluated: no.No, device evaluation anticipated, but not yet begun mfg date: 13-oct-2018 labeled for single use: no (b)(4).Heartware ventricular assist system battery model #: 1650 / catalog #: 1650 / expiration date: 31-oct-2019 / serial #: (b)(4) udi #: (b)(4) device evaluated: no.No, device evaluation anticipated, but not yet begun mfg date: 13-oct-2018 labeled for single use: no (b)(4).Heartware ventricular assist system battery model #: 1650 / catalog #: 1650 / expiration date: 31-oct-2019 / serial #: (b)(4) udi #: (b)(4) device evaluated: no.No, device evaluation anticipated, but not yet begun mfg date: 13-oct-2018 labeled for single use: no (b)(4).Heartware ventricular assist system battery model #: 1650 / catalog #: 1650 / expiration date: 31-oct-2021 / serial #: (b)(4), udi #: (b)(4) device evaluated: no.No, device evaluation anticipated, but not yet begun mfg date: 24-oct-2020 labeled for single use: no (b)(4).Heartware ventricular assist system battery model #: 1650 / catalog #: 1650 / expiration date: 31-oct-2021 / serial #: (b)(4), udi #: (b)(4) device evaluated: no.No, device evaluation anticipated, but not yet begun mfg date: 24-oct-2020 labeled for single use: no (b)(4).Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.
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A supplemental report is being submitted for device evaluation and investigation completion.Product event summary: one (1) controller (con309409) was returned for evaluation.Seven (7) batteries (bat755155, bat755157, bat805724, bat805735, bat805737, bat905710, bat905713) were not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the retuned device in relation to the reported event.Failure analysis of returned controller revealed that the device passed functional testing.Visual inspection of controller revealed contamination within both power ports and contamination within serial/data port.Additionally, visual inspection under 10x magnification revealed hairline cracks around both power ports.An internal inspection did not reveal evidence of fluid ingress.The observed contamination with the power ports and the hairline cracks are not related to the reported event.The most likely root cause of the observed contamination within the power ports.Can be attributed to handling of the device.Based on an investigation conducted under capa pr00381374, the root cause of the hairline cracks was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.Even though this capa is closed, con309409 falls within the bounds of this capa.Log file analysis revealed abnormalities relating to the relative state of charge (rsoc) involving bat905713 when the battery was in use; the battery was not estimating the capacity accurately.Analysis of the alarm log file revealed three (3) critical battery alarms involving bat905713 were logged on 08-jun-2021 at 16:35:04, on 10-jun-2021 at 23:20:51 and on 13-jun-2021 at 01:45:07.During the critical battery alarms, the battery dropped from 17% rsoc to 9% rsoc, 93% rsoc to 6% rsoc and 95% rsoc to 4% rsoc.During the critical battery alarms during 10-jun-2021 and 13-jun-2021, the battery was not the active battery, yet still dropped capacity.Log file analysis did not reveal any vad stopped alarms or loss of power events within the analyzed period.Additionally, a vad disconnect alarm was logged on 17-jun-2021 on 11:29:33, indicating a physical disconnection of the driveline from the controller, likely due to troubleshooting during the reported controller exchange.Review of event log file revealed multiple event exceptions associated with the serial/data port and controller reset events within the analyzed period.The controller reset events were likely triggered due to the event exceptions associated with the serial/data port.During supplemental testing, the controller was allowed to run for an extended period of time and results revealed that the event exceptions or controller resets could not be replicated.It is likely the observed event exceptions were related to the reported "data glitches".As a result, the reported critical battery alarm, abnormal battery behavior, "data glitches" events were confirmed.The reported fluid ingress event could not be confirmed due to insufficient evidence.The reported vad stopped alarm and loss of power event was not confirmed; however, it is likely the observed controller reset events were perceived the reported loss of power event.Given that the battery capacity suddenly depleted may be indicative of an estimation error.However, analysis could not be performed since the battery was not returned.The most likely root cause of the event exceptions associated with the serial/data port, and resulting controller resets, can be attributed but not limited to co ntamination within the serial port.The most likely root cause of the observed contamination within the serial port can be attributed to handling of the device.The most likely root cause of the reported critical battery alarms and associated abnormal battery beha vior event can be attributed to an estimation error, which resulted in the battery's capacity dropping below 10% rsoc, triggering critical battery alarms.Additional products: d4: serial #: (b)(6) h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: serial #: (b)(6) h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: serial #: (b)(6) h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: serial #: (b)(6) h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: serial #: (b)(6) h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: serial #: (b)(6) h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: serial #: (b)(6) h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c10 h6: fda conclusion code(s): d02 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.
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