HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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Model Number 1103 |
Device Problems
Moisture Damage (1405); Battery Problem (2885); Connection Problem (2900); Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: d1: heartware ventricular assist system ¿ controller 2.0, d4: model #: 1420, / catalog #: 1420, / expiration date: 31-jan-2022, / serial #: (b)(6), udi #: (b)(4), d9: no, h3: no, h4: mfg date: 22-jan-2021, h5: no, d1: heartware ventricular assist system ¿ battery, d4: model #: 1650, / catalog #: 1650, / expiration date: 31-aug-2024, / serial #: (b)(6), udi #: (b)(4), d9: no, h3: no, h4: mfg date: 11-aug-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.
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Event Description
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It was reported that the controller was dropped in water.A power disconnect alarm was logged and data log files were submitted for review.Review of log files data indicated that the ventricular assist device (vad) had exhibited above normal power consumption and that a battery had exhibited a communication error.The controller, battery, and vad remain in use. no patient complications have been reported as a result of this event.
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Event Description
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The high power was due to the patient's elevated hematocrit (hct).
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Manufacturer Narrative
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A supplemental report is being submitted for a correction.Updated b5.Investigation of this event is pending and a supplemental report will be sent upon its completion.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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Manufacturer Narrative
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A supplemental report is being submitted for additional information received.Updated b5.Investigation of this event is pending and a supplemental report will be sent upon its completion.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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Event Description
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It was further reported that the battery was exchanged.
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Search Alerts/Recalls
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