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Investigation of this event is pending and a supplemental report will be sent upon its completion continuation of concomitant medical products: 1103 vad, implanted (b)(6) 2019.Additional products: brand name: heartware ventricular assist system - battery / model #: 1650de / expiration date: 31-jul-2019 / serial or lot#: (b)(4) / udi #: (b)(4) / device available for evaluation: no / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / mfg date: 09-jul-2018 / labeled for single use: no / (b)(4).Brand name: heartware ventricular assist system - battery / model #: 1650de / expiration date: 31-jul-2019 / serial or lot#: (b)(4) / udi #: (b)(4) / device available for evaluation: no / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / mfg date: 09-jul-2018 / labeled for single use: no / (b)(4).Brand name: heartware ventricular assist system - battery / model #: 1650de / expiration date: 31-jul-2019 / serial or lot#: (b)(4) / udi #: (b)(4) / device available for evaluation: no / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / mfg date: 09-jul-2018 / labeled for single use: no / (b)(4).Brand name: heartware ventricular assist system - battery / model #: 1650de / expiration date: 31-jul-2019 / serial or lot#: (b)(4) / udi #: (b)(4) / device available for evaluation: no / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / mfg date: 09-jul-2018 / labeled for single use: no / (b)(4).Brand name: heartware ventricular assist system - battery / model #: 1650de / expiration date: 31-jul-2019 / serial or lot#: (b)(4) / udi #: (b)(4) / device available for evaluation: no / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / mfg date: 09-jul-2018 / labeled for single use: no / (b)(4).Brand name: heartware ventricular assist system - battery / model #: 1650de / expiration date: 31-jul-2019 / serial or lot#: (b)(4) / udi #: (b)(4) / device available for evaluation: no / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / mfg date: 09-jul-2018 / labeled for single use: no (b)(4).If information is provided in the future, a supplemental report will be issued.
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###a supplemental is being submitted for additional information.Product event summary: one (1) controller ((b)(6)) was not returned for evaluation.Six (6) batteries ((b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6),) were returned for evaluation.Various analyses were conducted and reviewed 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.Functional testing of the batteries revealed abnormalities relating to the relative state of charge (rsoc); the batteries were not estimating the capacity accurately.This is an additional observation not related to the reported event and can be attributed can be attributed to an estimation error.Log file analysis revealed that the controller in use during the reported event, (b)(6), contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the data log file revealed premature power switching events that were due to momentary disconnections involving (b)(6), (b)(6), and (b)(6).Analysis of the data log file revealed several momentary disconnections that did not lead premature power switching involving (b)(6), (b)(6), (b)(6), (b)(6), (b)(6) and (b)(6).Momentary disconnections will lead to an audible tone or ¿beeping¿.As a result, the reported power switching, and ¿intermittent beeping¿ events were confirmed.The reported poor mechanical connection on the controller event could not be confirmed.There is no evidence that a power source lubrication procedure was performed on the associated batteries.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported poor mechanical connection on the controller event can be attributed, but not limited, to connector damage, bent pins, and/or connector wiring failure.The most likely root cause of the reported premature power switching event can be attributed, but not limited, to momentary disconnections due to temporary corrosion of the controller-port/power-source pins.The most likely root cause of the reported intermittent beeping event can be attributed to momentary disconnections between the controller and batteries.Capa (b)(4) investigated momentary disconnections prior to lubrication servicing.Even though this capa is closed, (b)(6) , (b)(6) , (b)(6) , and (b)(6) fall within the bounds of this capa.Additional products: (b)(6)- battery d9: yes, return date: 18-may-2022 h3: yes dev rtn to mfr? yes h6: fda img (annex g) component: g0403401 h6: fda method code(s): b01, b15 h6: fda results code(s): c10, c04 h6: fda conclusion code(s): d02, d01 (b)(6)- battery d9: yes, return date: 18-may-2022 h3: yes dev rtn to mfr? yes h6: fda img (annex g) component: g0403401 h6: fda method code(s): b01, b15 h6: fda results code(s): c10, c04 h6: fda conclusion code(s): d02, d01 (b)(6)- battery d9: yes, return date: 18-may-2022 h3: yes dev rtn to mfr? yes h6: fda img (annex g) component: g0403401 h6: fda method code(s): b01, b15 h6: fda results code(s): c10, c04 h6: fda conclusion code(s): d02, d01 (b)(6)- battery d9: yes, return date: 18-may-2022 h3: yes dev rtn to mfr? yes h6: fda img (annex g) component: g0403401 h6: fda method code(s): b01, b15 h6: fda results code(s): c10, c04 h6: fda conclusion code(s): d02, d01 (b)(6)- battery d9: yes, return date: 18-may-2022 h3: yes dev rtn to mfr? yes h6: fda img (annex g) component: g0403401 h6: fda method code(s): b01, b15 h6: fda results code(s): c10, c04 h6: fda conclusion code(s): d02, d01 (b)(6)- battery d9: yes, return date: 18-may-2022 h3: yes dev rtn to mfr? yes h6: fda img (annex g) component: g0403401 h6: fda method code(s): b01, b15 h6: fda results code(s): c10, c04 h6: fda conclusion code(s): d02, d01 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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