MEDTRONIC EUROPE SARL COBALT¿ HF CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTPB2D4 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2024 |
Event Type
Injury
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Manufacturer Narrative
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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 during use of the cardiac resynchronization therapy defibrillator (crt-d) there was suspected early battery depletion. a review of the crt-d data revealed there was no evidence of abnormal depletion; the reason for the less than one month estimation mainly due to the left ventricular (lv) lead pacing amplitude and pulse width. the lv feature that monitors and auto adjust output had been adjusting the lv output to high and varying values because of the high capture measurements, as well as the patient¿s heart pacing rate, associated leads pacing rate, resulted in high battery current drain. however, according to the most recent crt-d data and lv capture trend, the lv capture measurements have been trending down since approximately four months prior, therefore the battery voltage is slowly recovering due to decrease in current drain. the crt-d and lv lead 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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It was also reported that reprogramming was performed to decrease the output.
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Manufacturer Narrative
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Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated that the battery had not yet reached its recommended replacement time.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.
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Event Description
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It was reported that during use of the cardiac resynchronization therapy defibrillator (crt-d) there was suspected early battery depletion. a review of the crt-d data revealed there was no evidence of abnormal depletion; the reason for the less than one month estimation mainly due to the left ventricular (lv) lead pacing amplitude and pulse width. the lv feature that monitors and auto adjust output had been adjusting the lv output to high and varying values because of the high capture measurements, as well as the patient¿s heart pacing rate, associated leads pacing rate, resulted in high battery current drain. however, according to the most recent crt-d data and lv capture trend, the lv capture measurements have been trending down since approximately four months prior, therefore the battery voltage is slowly recovering due to decrease in current drain. the crt-d and lv lead remain in use. it was reported that the remote monitoring network report displayed optivol event invalid data.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Correction: b5.Desc evt problem.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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