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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1103 |
| Device Problems
Electrical /Electronic Property Problem (1198); Moisture Damage (1405); Pumping Stopped (1503); Connection Problem (2900); Power Problem (3010); Pumping Problem (3016)
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| Patient Problems
Headache (1880); No Code Available (3191); Suicidal Ideation (4429); Myocardial Hypertrophy (4447); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 08/17/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Additional products: brand name: heartware ventricular assist system ¿controller 2.0, model #: 1420, catalog #: 1420, expiration date: 31-dec-2019, serial#: (b)(4), udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 31-dec-2018.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿controller 2.0, model #: 1420, catalog #: 1420, expiration date: 30-sep-2019, serial#: (b)(4), udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 28-sep-2018.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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Event Description
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It was reported that while the patient was taking a bath, they were unsure if their driveline was unplugged or came undone from the primary controller, triggering ventricular assist device (vad) disconnect alarms.The patient was unable to give a clear history of the event and there was a concern for water damage to their primary and back up controller.After log file review, it was seen that the primary controller exhibited multiple electrical faults and unexpected power losses with prolonged vad stop time.The patient then switched to their back up controller, which was also thought to be damaged.It was further reported, that five days later, there was subsequent driveline disconnects and electrical faults on the back up controller, as a result the vad failed to start.There was no damage noted at the driveline connection site.The vad coordinator stated that the patient's mental status appeared to have worsen and when the patient was in the emergency room, the patient was trying to ¿disconnect things¿.It was noted that there was a power disconnect alarm on the primary controller.The patient¿s results were negative for their brain computerized tomography (ct) and the patient was discharged.The vad and primary controller remain in use.The backup controller was exchanged.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A supplemental report is being submitted for device analysis.Product event summary: one (1) controller ((b)(4)) was returned for evaluation.The ventricular assist device (vad) ((b)(4)) and one (1) controller ((b)(4)) were not 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 controller ((b)(4) ) revealed that the unit passed visual inspection and functional testing.Visual inspection revealed no signs of contamination within the driveline connector port of the controller.An internal inspection did not reveal any evidence of fluid ingress.As a result, the reported fluid ingress event for (b)(4) could not be confirmed.Supplemental testing revealed that the driveline connector port functioned as intended with no anomalies.Log file analysis revealed that (b)(4) was the patient's primary controller, initially in use at the time of the event.Analysis of the event log file associated with (b)(4) revealed that the controller had experienced a corruption resulting in error conditions on (b)(6) 2020 starting at 05:28:34.This corruption forced the user interface controller, which is the main integrated chip responsible for the operations of the controller, to perform resets.Analysis of (b)(4) event log file also revealed a controller power up event on (b)(6) 2020 at 08:06:11.The data point prior to the loss of power revealed that (b)(4) was connected to power port one (1) with 83% relative state of charge (rsoc) and (b)(4) was connected to power port two (2) with 70% rsoc.The data point recorded after the loss of power revealed that (b)(4) was connected to power port one (1) and no power source was connected to power port two (2).The controller was without power for 18 minutes and 34 seconds.Analysis of (b)(4) alarm log file revealed four (4) vad disconnect alarms logged on (b)(6) 2020 between 22:56:23 and 23:05:12, indicating physical disconnections of the driveline from the controller, likely during the reported controller exchange.Log file analysis revealed that, following the vad disconnect alarms, (b)(4) was in use.Analysis of (b)(4) alarm log file revealed eight (8) vad disconnect alarms, one (1) high watt alarm, two (2) electrical fault alarms, and two (2) vad stopped alarms logged on (b)(6) 2020.A vad disconnect alarm was logged at 07:25:12 indicating a physical disconnection of the driveline from the controller.The vad disconnect alarm resolved at 07:26:18, indicating that the driveline cable was connected to the controller.Analysis of (b)(4) event log file revealed that multiple reactivation events were logged on (b)(6) 2020 starting at 07:26:25 due to an open phase on the front stator, resulting in the pump running on the rear stator only.This likely triggered the subsequent high watt alarm logged at 07:26:30 due to the increased power consumption required to run on a single stator.An electrical fault alarm was then logged at 07:26:34, indicating an open phase on the front stator.Three (3) vad disconnect alarms were subsequently logged between 07:26:36 and 07:27:44 due to open phases on both stators.Another electrical fault alarm was then logged at 07:28:53, indicating that the front stator was not connected.Two (2) vad stopped alarms were logged at 07:30:01 and 07:30:45, indicating that the pump failed to restart after several attempts.Four (4) additional vad disconnect alarms were logged between 07:34:46 and 07:39:43 due to physical disconnections of the driveline from the controller, likely during troubleshooting and the reported controller exchange.Log file analysis revealed that (b)(4) was then in use again.Analysis of (b)(4) alarm log file revealed that four (4) additional vad disconnect alarms and one (1) additional electrical fault alarm were logged on (b)(6) 2020.Two (2) vad disconnect alarms were logged at 16:59:45 and 17:15:21, indicating a physical disconnection of the driveline from the controller.A vad disconnect alarm was then logged at 17:16:58 due to open phases on both stators.An electrical fault alarm was logged at 17:17:02, indicating that the front stator was not connected.This was followed by an additional vad disconnect alarm logged at 17:17:06, indicating a physical disconnection of the driveline from the controller.Of note, the log files associated with (b)(4) revealed multiple controller power up events without associated motor start events and a vad disconnect alarm logged on (b)(6) 2020, likely due to troubleshooting of the controller after the controller exchange had been performed; only one battery was connected to the controller and the data log file indicated that the power disconnect alarm was active, which corresponds with the reported power disconnect alarm.As a result, the reported controller loss of power, electrical faults alarms, vad disconnect alarms, high power, vad stopped alarms events, and power disconnect alarm events were confirmed.A possible root cause of the reported fluid ingress event for (b)(4) can be attributed, but not limited, to the handing of the device, as described in the event details.A possible root cause of the observed uic resets can be attributed, but not limited to a faulty or corrupted user interface controller, potentially due to fluid ingress associated with the reported handling of the device as described in the reported event details.Based on the available information, the most likely root cause of the initial loss of power involving (b)(4) can be attributed to a disconnection of both power sources from the controller.Capa pr(b)(4) is investigating controller losses of power.Based on the available information, the most likely root cause of the following controller power up events can be attributed to controller exchanges and/or troubleshooting of alarms.The most likely root cause of several of the vad disconnect alarms can be attributed to a physical disconnection of the driveline from the controller.Based on risk documentation and the available information, a possible root cause of the reported electrical faults alarms, the high watt alarm, and several of the vad disconnect alarms can be attributed, but not limited, to a marginal driveline connection or contamination by foreign material of the driveline connector.The most likely root cause of the vad stopped alarms can be attributed to failure of the pump to restart after several attempts.(b)(4) is not in scope of fca cvg-21-q3-21.Capa (b)(4) is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.The most likely root cause of the reported power disconnect alarm can be attributed to a controller connected to only one power source during troubleshooting after the controller exchange.Of note, information received from the site indicated that the patient presented with a headache upon admission and the patient's mental status appeared to have worsened.It was further reported that, when the patient was in the emergency room, the patient was trying to ¿disconnect things.¿ the patient¿s results were negative for their brain computerized tomography (ct) and the patient was discharged.It was further reported that the patient was readmitted for paranoia and suicidal ideation and admitted to having a gun.The patient was awaiting placement to a rehab facility.It was also reported that an echocardiogram and chest computerized tomography (ct) showed hypertrophy in the left and right ventricles with no thrombus.Per the instructions for use, neurological dysfunction is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history stroke with multifocal large territory infarcts in the cerebral arteries.Of note, it was reported by the site that the patient has a significant family history of mental health issues (schizophrenia) to which the patient has tendencies.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and anti platelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.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.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 patient presented with a headache upon admission.
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Manufacturer Narrative
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A supplemental report is being submitted due to additional information received.Additional information received regarding patient demographics, relevant history, and patient symptoms.D1: heartware ventricular assist system ¿controller 2.0, d4: serial#: (b)(6), h3: no, device evaluation anticipated, but not yet begun.H6: patient code(s): c34661, d1: heartware ventricular assist system ¿controller 2.0, d4: serial#: (b)(6), h3: no, device evaluation anticipated, but not yet begun.H6: patient code(s): c34661.This information was received from the hvad destination therapy post approval study.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 a correction.Pli codes were updated additional products: d1: heartware ventricular assist system ¿controller 2.0 d4: serial #: (b)(6), h6: patient ime code(s): e2402 h6: imf code(s): f11, f08, f2203, f28 h6: fda device code(s): a12 d1: heartware ventricular assist system ¿controller 2.0 d4: serial#: (b)(6), h6: patient ime code(s): e2402 h6: imf code(s): f11, f08, f2203, f28 h6: fda device code(s): a12 was removed h.6 fda patient codes and device codes were added 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.
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Manufacturer Narrative
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A supplemental report is being submitted for investigation summary.Product event summary: one (1) controller was returned for evaluation.The pump and one (1) controller were not 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 controller (b)(6) revealed that the unit passed visual inspection and functional testing.Visual inspection revealed no signs of contamination within the driveline connector port of the controller.An internal inspection did not reveal any evidence of fluid ingress.As a result, the reported fluid ingress event for (b)(6) could not be confirmed.Supplemental testing revealed that the driveline connector port functioned as intended with no anomalies.Log file analysis revealed that (b)(6) was the patient's primary controller, initially in use at the time of the event.Analysis of the event log file associated with (b)(6) revealed that the controller had experienced a corruption resulting in error conditions on (b)(6) 2020 starting at 05:28:34.This corruption forced the user interface controller, which is the main integrated chip responsible for the operations of the controller, to perform resets.Analysis of (b)(6) event log file also revealed a controller power up event on (b)(6) 2020 at 08:06:11.The data point prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 83% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 70% rsoc.The data point recorded after the loss of power revealed that (b)(6) was connected to power port one (1) and no power source was connected to power port two (2).The controller was without power for 18 minutes and 34 seconds.Analysis of (b)(6) alarm log file revealed four (4) vad disconnect alarms logged on (b)(6) 2020 between 22:56:23 and 23:05:12, indicating physical disconnections of the driveline from the controller, likely during the reported controller exchange.Log file analysis revealed that, following the vad disconnect alarms, (b)(6) was in use.Analysis of (b)(6) alarm log file revealed eight (8) vad disconnect alarms, one (1) high watt alarm, two (2) electrical fault alarms, and two (2) vad stopped alarms logged on (b)(6) 2020.A vad disconnect alarm was logged at 07:25:12 indicating a physical disconnection of the driveline from the controller.The vad disconnect alarm resolved at 07:26:18, indicating that the driveline cable was connected to the controller.Analysis of (b)(6) event log file revealed that multiple reactivation events were logged on (b)(6) 2020 starting at 07:26:25 due to an open phase on the front stator, resulting in the pump running on the rear stator only.This likely triggered the subsequent high watt alarm logged at 07:26:30 due to the increased power consumption required to run on a single stator.An electrical fault alarm was then logged at 07:26:34, indicating an open phase on the front stator.Three (3) vad disconnect alarms were subsequently logged between 07:26:36 and 07:27:44 due to open phases on both stators.Another electrical fault alarm was then logged at 07:28:53, indicating that the front stator was not connected.Two (2) vad stopped alarms were logged at 07:30:01 and 07:30:45, indicating that the pump failed to restart after several attempts.Four (4) additional vad disconnect alarms were l ogged between 07:34:46 and 07:39:43 due to physical disconnections of the driveline from the controller, likely during troubleshooting and the reported controller exchange.Log file analysis revealed that (b)(6) was then in use again.Analysis of (b)(6) alarm log file revealed that four (4) additional vad disconnect alarms and one (1) additional electrical fault alarm were logged on (b)(6) 2020.Two (2) vad disconnect alarms were logged at 16:59:45 and 17:15:21, indicating a physical disconnection of the driveline from the controller.A vad disconnect alarm was then logged at 17:16:58 due to open phases on both stators.An electrical fault alarm was logged at 17:17:02, indicating that the front stator was not connected.This was followed by an additional vad disconnect alarm logged at 17:17:06, indicating a physical disconnection of the driveline from the controller.Of note, the log files associated with (b)(6) revealed multiple controller power up events without associated motor start events and a vad disconnect alarm logged on (b)(6) 2020, likely due to troubleshooting of the controller after the controller exchange had been performed; only one battery was connected to the controller and the data log file indicated that the power disconnect alarm was active, which corresponds with the reported power disconnect alarm.As a result, the reported controller loss of power, electrical faults alarms, vad disconnect alarms, vad stopped alarms events, and power disconnect alarm events were confirmed.A possible root cause of the reported fluid ingress event for (b)(6) can be attributed, but not limited, to the handing of the device, as described in the event details.A possible root cause of the observed uic resets can be attributed, but not limited to a faulty or corrupted user interface controller, potentially due to fluid ingress associated with the reported handling of the device as described in the reported event details.Based on the available information, the most likely root cause of the initial loss of power involving (b)(6) can be attributed to a disconnection of both power sources from the controller.Based on the available information, the most likely root cause of the following controller power up events can be attributed to controller exchanges and/or troubleshooting of alarms.The most likely root cause of several of the vad disconnect alarms can be attributed to a physical disconnection of the driveline from the controller.Based on risk documentation and the available information, a possible root cause of the reported electrical faults alarms, the observed high watt alarm, and several of the vad disconnect alarms can be attributed, but not limited, to a marginal driveline connection or contamination by foreign material of the driveline connector.The most likely root cause of the vad stopped alarms can be attributed to failure of the pump to restart after several attempts.Capa pr00502194 is investigating pump failures to restart.The most likely root cause of the reported power disconnect alarm can be attributed to a controller connected to only one power source during troubleshooting after the controller exchange.Of note, information received from the site indicated that the patient presented with a headache upon admission and the patient's mental status appeared to have worsened.It was further reported that, when the patient was in the emergency room, the patient was trying to ¿disconnect things.¿ the patient¿s results were negative for their brain computerized tomography (ct) and the patient was discharged.Per the instructions for use, neurological dysfunction is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history stroke with multifocal large territory infarcts in the cerebral arteries.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Additional products: d1: heartware ventricular assist system ¿controller 2.0.D4: serial # : (b)(6).H6: fda method code(s): b01, b15.H6: fda results code(s): c04, c19.H6: fda conclusion code(s): d15, d10.D1: heartware ventricular assist system ¿controller 2.0.D4: serial # : (b)(6).H6: fda method code(s):b15, b17.H6: fda results code(s): c04, c02.H6: fda conclusion code(s): d15,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.
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Manufacturer Narrative
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A supplemental report is being submitted for correction.Correction b1: adv evnt/prod prob was corrected from product problem to adverse event product problem.Correction b2: outcome attributed to adverse event was updated to hospitalization.Correction h6: the imf code was corrected from f11 to f12.Additional products: d1: heartware ventricular assist system ¿controller 2.0 d4: serial (b)(6) h6: imf code(s): f12 d1: heartware ventricular assist system ¿controller 2.0 d4: serial#: (b)(6).H6: imf code(s): f12 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.(b)(6) 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.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 as a new internal investigation has been assigned to this event.Also, updated section h6 codes.The ventricular assist device (vad) is not in scope of capa pr00502194, and capa pr00532915 was initiated to investigate pump failures to restart outside the subpopulation of capa pr00502194.Investigation is pending.A report will be sent when root cause for the internal investigation has been determined.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 while the patient was taking a bath, they were unsure if their driveline was unplugged or came undone from the primary controller, triggering ventricular assist device (vad) disconnect alarms.The patient was unable to give a clear history ofthe event and there was a concern for water damage to their primary and back up controller.After log file review, it was seen that the primary controller exhibited multiple electrical faults and unexpected power losses with prolonged vad stop time.The patient then switched to their back up controller, which was also thought to be damaged.It was further reported, that five days later, there was subsequent driveline disconnects and electrical faults on the back up controller, as a result the vad failed to start.There was no damage noted at the driveline connection site.The vad coordinator stated that the patient's mental status appeared to have worsen and when the patient was in the emergency room, the patient was trying to ¿disconnect things¿.It was noted that there was a power disconnect alarm on the primary controller.The patient was hospitalized and reported a headache upon admission.The patient¿s results were negative for their brain computerized tomography (ct) and the patient was discharged.The vad and primary controller rema in in use.The backup controller was exchanged.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A supplemental report is being submitted for a correction.Corrected fields: h1 type of report: updated to serious injury b5 event description was updated this regulatory report is being submitted as part of a retrospective review and remediation per (b)(6) due to an fda audit observation.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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This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.A correction supplemental report is being submitted for the event details and coding.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 patient was readmitted for paranoia and suicidal ideation and admitted to having a gun.There was noted to be a significant family history of mental health issues (schizophrenia) to which the patient has tendencies.The patient was awaiting placement to a rehab facility.It was also reported that an echocardiogram and chest computerized tomography (ct) showed hypertrophy in the left and right ventricles with no thrombus.It was also reported that the ventricular assist device (vad)exhibited above normal power which were associated with high watt alarms.
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Search Alerts/Recalls
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