This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Other devices involved in this event: battery/ (b)(4) / model #1650de / exp.Date: 03/31/2016 /udi#: (b)(4), device available for evaluation: no, device mfg.Date: 03/31/2015, labeled for single use: no.This event was assessed and is being reported as part of a retrospective review of log file data.If information is provided in the future, a supplemental report will be issued.
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Product event summary: the controller and one battery were not returned for evaluation.As a result, the reported event could not be confirmed.A review of the manufacturing documentation confirmed that the associated controller met all requirements for release.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of loose power port connector on the controller may be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.A possible root cause of a poor mechanical connection on the battery may be attributed, but not limited to, connector damage or connector wiring failure.Additional products: (b)(4), battery h6: method code(s): fda 4114 h6: result code(s): fda 3221 h6: conclusion code(s): fda 67 medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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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