Concomitant medical products: product id: ddmb1d4 icd, implanted: (b)(6) 2018, lead 5076-45, implanted: (b)(6) 2018, lead 6935m55, implanted: (b)(6) 2018.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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It was reported that the controller exhibited a controller fault alarm.The patient had been stable, but while the patient's catheter was being adjusted, the controller got wet and a controller fault alarm occurred due to depleted internal battery.The controller was exchanged.No patient complications have been reported as a result of this event.
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A supplemental report is being submitted for device evaluation product event summary: the controller was not returned for evaluation.Review of the controller log files revealed a controller fault alarm was logged on (b)(6) 2020 at 20:56:11, indicating an issue with internal battery.Additionally, log files revealed that the controller was in use for less than 2 years.As a result, the reported controller fault alarm event was confirmed.The reported "controller got wet" event could not be confirmed due to insufficient evidence.Based on the limited information available, a possible root cause of the reported "controller got wet" event can be attributed, but not limited to handling of the device.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported controller fault alarm may be attributed, but not limited, to a faulty internal nimh battery and/or a faulty internal battery charger integrated circuit.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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